Medical devices, 2015
Shortlist up to four to read them side by side.
2,495 medical device recalls FDA’s Enforcement Report published in 2015, newest first; 40,450 in all since 2012.
FDA’s medical device recalls, as its Enforcement Report classifies them, from June 2012. Lists of FDA’s records can’t be saved for alerts: openFDA asks that its data not be used to alert the public (openFDA); FDA’s own emails do that. Copied Nov 6, 2026.
2,495of 2,495 medical device recallsshown with your filters
The list
- Medical device recall CRIT-LINE Blood Chamber- an accessory to the Crit line III- Monitors in real time blood parameters Blood chamber connection leaks during the use of the CRIT-LINE¿ Blood Chamber Class IIFDA’s classJun 17, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 17, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Extentrac Elite product brochure DCN: 13-001, 09-001 (Powered decompression table, for traction) Item is marketed for use in patients weighing up to 350 lbs, but the device was only approved for use in patients up to 300 lbs Class IIFDA’s classJun 17, 2015in FDA’s Enforcement Report5 statesnamed in where it went PublishedJun 17, 2015ClassClass IIStatusTerminatedWhereCalifornia, Florida, New Jersey, Texas and Washington
- Medical device recall Extentrac Elite User Manual DCN: 14-001 (Powered decompression table, for traction) Item is marketed for use in patients weighing up to 350 lbs, but the device was only approved for use in patients up to 300 lbs Class IIFDA’s classJun 17, 2015in FDA’s Enforcement Report5 statesnamed in where it went PublishedJun 17, 2015ClassClass IIStatusTerminatedWhereCalifornia, Florida, New Jersey, Texas and Washington
- Medical device recall Laksell GammaPlan, a computer based dose planning system specifically designed for use with Leksell Gamma… Memory can become corrupted when creating a fused study via drag and drop in Leksell GammaPlan 10.2. Class IIFDA’s classJun 17, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedJun 17, 2015ClassClass IIStatusTerminatedWhereNationwide, and Illinois, Ohio, Pennsylvania, Texas and Wisconsin named
- Medical device recall Roscoe Mini Neb Compressor User Manual for the NEB-ROS Product Usage: Inhaler therapy that converts liquid… Roscoe Medical has recently identified the need to update its user manual with additional warning statements regarding proper handling and storage of the… Class IIFDA’s classJun 17, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 47 states named PublishedJun 17, 2015ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Vilex, Inc., FUZE 10.0 mm x 150 mm, Product # FZ100-150T-25 Incidence of breakage is higher than expected. Class IIFDA’s classJun 17, 2015in FDA’s Enforcement Report4 statesnamed in where it went PublishedJun 17, 2015ClassClass IIStatusTerminatedWhereMaryland, Mississippi, Pennsylvania and Texas
- Medical device recall Vilex, Inc., FUZE 10.0 mm x 200 mm, Product # FZ100-200T-25 Incidence of breakage is higher than expected. Class IIFDA’s classJun 17, 2015in FDA’s Enforcement Report4 statesnamed in where it went PublishedJun 17, 2015ClassClass IIStatusTerminatedWhereMaryland, Mississippi, Pennsylvania and Texas
- Medical device recall Vilex, Inc., FUZE 10.0 mm x 250 mm, Product # FZ100-250T-25 Incidence of breakage is higher than expected. Class IIFDA’s classJun 17, 2015in FDA’s Enforcement Report4 statesnamed in where it went PublishedJun 17, 2015ClassClass IIStatusTerminatedWhereMaryland, Mississippi, Pennsylvania and Texas
- Medical device recall enGen Laboratory Automation System (enGen System) Recapper Caps may fall off of, or be knocked from sample tubes placed in the storage racks of entry/exit modules. Class IIFDA’s classJun 17, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 17, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Alkaline Wash, List number 9D31-20, a cleaning solution used by the Abbott Architect analyzers The product is leaking from the cap and crystallization was noted as present around the cap. Class IIFDA’s classJun 17, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 17, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall HeartWare Ventricular Assist System (HVAD) Complaints with the HVAD Retraction of Pins within the driveline connector. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 17, 2015in FDA’s Enforcement Report32 statesnamed in where it went PublishedJun 17, 2015ClassClass IStatusOngoingWhereAlabama, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Hampshire, New Jersey, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah and Virginia
- Medical device recall Ally Uterine Positioning System (Ally UPS) used in the mounting and positioning and holding of uterine… Design of device may expose user to injury to fingers or body parts Class IIFDA’s classJun 17, 2015in FDA’s Enforcement Report4 statesnamed in where it went PublishedJun 17, 2015ClassClass IIStatusTerminatedWhereCalifornia, Illinois, North Carolina and New York
- Medical device recall VITROS 5,1 FS Chemistry System, Software Version 2.8 & Below Automates pre-analytical and post-analytical… Software anomaly regarding urine samples that require acidified pretreatment. Class IIFDA’s classJun 17, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 17, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Assay Data Disk (ADD), All DRV versions that support product within expiry dating Automates pre-analytical… Software anomaly regarding urine samples that require acidified pretreatment. Class IIFDA’s classJun 17, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 17, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Low Volume Extension Set, 72’ w/Clamp FLL/MLL APV=1.3ml, STERILE, AND FLUID PATH NONPYROGENIC UNLESS PACKAGE… Smiths Medical has become aware of an issue with the Low Volume Extension Set, (72’’ Extension Set) where under-sized tubing was used in the production of 1… Class IIFDA’s classJun 17, 2015in FDA’s Enforcement Report5 statesnamed in where it went PublishedJun 17, 2015ClassClass IIStatusTerminatedWhereKentucky, Minnesota, New Jersey, Utah and Wisconsin
- Medical device recall ClearSight, Model No. EVHRS Heart Reference Sensor. The EV1000 Clinical Platform Nl and ClearSight finger… Edward Lifesciences is recalling the ClearSight System because the finger component of the Heart Reference Sensor may be damaged. Class IIFDA’s classJun 17, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 17, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall AccuChek Spirit Combo insulin infusion pump Roche has become aware of an increase of mechanical errors experienced by customers using the Accu-Chek Spirit Combo insulin infusion pump and Accu-Chek Spirit… Class IIFDA’s classJun 17, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 17, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall AccuChek Spirit insulin infusion pump. Roche has become aware of an increase of mechanical errors experienced by customers using the Accu-Chek Spirit Combo insulin infusion pump and Accu-Chek Spirit… Class IIFDA’s classJun 17, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 17, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall R3(TM) 22 MM I.D., 52 MM O.D The R3 Constrained outer liner locking groove diameter is 0.030 inches oversized and may not allow the locking ring to engage into the R3 shell. Class IIFDA’s classJun 17, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedJun 17, 2015ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Illinois, Indiana, Michigan, Nebraska, New York, Tennessee, Texas, Virginia and Wisconsin named
- Medical device recall R3(TM) 22 MM I.D., 56 MM O.D The R3 Constrained outer liner locking groove diameter is 0.030 inches oversized and may not allow the locking ring to engage into the R3 shell. Class IIFDA’s classJun 17, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedJun 17, 2015ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Illinois, Indiana, Michigan, Nebraska, New York, Tennessee, Texas, Virginia and Wisconsin named
- Medical device recall R3(TM) 22 MM I.D., 58 MM O.D The R3 Constrained outer liner locking groove diameter is 0.030 inches oversized and may not allow the locking ring to engage into the R3 shell. Class IIFDA’s classJun 17, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedJun 17, 2015ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Illinois, Indiana, Michigan, Nebraska, New York, Tennessee, Texas, Virginia and Wisconsin named
- Medical device recall R3(TM) 28 MM I.D., 60 MM O.D The R3 Constrained outer liner locking groove diameter is 0.030 inches oversized and may not allow the locking ring to engage into the R3 shell. Class IIFDA’s classJun 17, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedJun 17, 2015ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Illinois, Indiana, Michigan, Nebraska, New York, Tennessee, Texas, Virginia and Wisconsin named
- Medical device recall R3(TM) 28 MM I.D., 62 MM O.D The R3 Constrained outer liner locking groove diameter is 0.030 inches oversized and may not allow the locking ring to engage into the R3 shell. Class IIFDA’s classJun 17, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedJun 17, 2015ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Illinois, Indiana, Michigan, Nebraska, New York, Tennessee, Texas, Virginia and Wisconsin named
- Medical device recall RELIEVA FLEX Sinus Guide Catheter F-70 Acclarent determined that one single RELIEVA FLEX Sinus Guide Catheter was distributed past it’s expiry date. Class IIIFDA’s classJun 17, 2015in FDA’s Enforcement ReportTexasthe one state its words name PublishedJun 17, 2015ClassClass IIIStatusTerminatedWhereTexas
- Medical device recall Unilateral external fixation ankle clamp Product Usage: Unilateral external fixation for use treatment of… Ankle clamp was assembled incorrectly; the offset of the pin to the pivot point is reversed. Class IIFDA’s classJun 17, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedJun 17, 2015ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Michigan, North Carolina and Texas named
- Medical device recall VITROS 4600 Chemistry System, Software Version 3.2 & Below Software anomaly allows testing of multiple assays using a single urine specimen, regardless of the pretreatment requirements for each selected assay,… Class IIFDA’s classJun 17, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 17, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall VITROS 5600 Chemistry System, Software Version 3.2 & Below Software anomaly allows testing of multiple assays using a single urine specimen, regardless of the pretreatment requirements for each selected assay,… Class IIFDA’s classJun 17, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 17, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall The Optigun Ratchet is a hand-held cement gun for use with Optivac The pin which maintains the knob button, may disconnect and become lost. Class IIFDA’s classJun 17, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 17, 2015ClassClass IIStatusTerminatedWhereNationwide, and Maryland named
- Medical device recall AGFA DX-D 100 is a mobile digital radiography x-ray system When using the DX-D 100 unit, sporadic unintended movements caused by an electrostatic discharge of the unit to the ground may occur. Class IIFDA’s classJun 17, 2015in FDA’s Enforcement Report29 statesnamed in where it went PublishedJun 17, 2015ClassClass IIStatusTerminatedWhereAlabama, California, District of Columbia, Florida, Georgia, Iowa, Illinois, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New York, Ohio, Oklahoma, Oregon, South Carolina, Tennessee, Texas, Virginia, Wisconsin, West Virginia and Wyoming
- Medical device recall BBL Port A Cul tubes The products may exhibit indications of excessive oxidation. Class IIFDA’s classJun 17, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 47 states named PublishedJun 17, 2015ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall BBL Port A Cul tubes with Swabs Sterile Pack The products may exhibit indications of excessive oxidation. Class IIFDA’s classJun 17, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 47 states named PublishedJun 17, 2015ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Remel Blood Agar (TSA w/sheep blood) plate Product may be contaminated with Listeria monocytogenes. Class IIFDA’s classJun 17, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 17, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ORTHOFIX Firebird Spinal Fixation System 6.5mm x 55mm Multi-Axial Screw, Standard Implant Grade Titanium Alloy The Firebird Spinal Fixation System 6.5 mm x 55 mm Bone Screw, Self-Tapping is currently mislabeled at the distal tip of the bone screw showing a length… Class IIFDA’s classJun 17, 2015in FDA’s Enforcement Report9 statesnamed in where it went PublishedJun 17, 2015ClassClass IIStatusTerminatedWhereCalifornia, Colorado, Florida, Maryland, Michigan, New York, Oklahoma, Pennsylvania and South Carolina
- Medical device recall Astral 100 ( The Astral device allows clinicians to disable all alarms including those that detect circuit disconnection. Class IIFDA’s classJun 17, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 17, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall HeartWare Ventricular Assist System (HVAD) For use as a bridge-to-cardiac transplantation in patient who are… Complaints with the HVAD Discolored and Cracked Driveline Outer Sheath. Class IIFDA’s classJun 17, 2015in FDA’s Enforcement Report32 statesnamed in where it went PublishedJun 17, 2015ClassClass IIStatusOngoingWhereAlabama, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Hampshire, New Jersey, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah and Virginia
- Medical device recall Gyrus ACMI Diego Elite Tubeset Potential lack of sterility assurance. Class IIFDA’s classJun 17, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 17, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Gyrus ACMI Diego Elite Tubeset, intended for cutting, coagulation, drilling, debriding, and removal of bone,… Potential lack of sterility assurance. Class IIFDA’s classJun 17, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 17, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Mallory/Head Primary Hip System Biomet hip joint, knee joint and shoulder joint replacement components device labeling contains incorrect GTIN (Global Trade Identification Number) codes. Class IIIFDA’s classJun 17, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 25 states named PublishedJun 17, 2015ClassClass IIIStatusTerminatedWhereNationwide, and Alabama, Arkansas, California, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, North Carolina, New Jersey, Nevada, Ohio, Pennsylvania, South Dakota, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Comprehensive Shoulder System, 4 mm, 122 mm long, Primary Shoulder Stem, Ti-6Al-4V, Standard Length Porous… Biomet hip joint, knee joint and shoulder joint replacement components device labeling contains incorrect GTIN (Global Trade Identification Number) codes. Class IIIFDA’s classJun 17, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 25 states named PublishedJun 17, 2015ClassClass IIIStatusTerminatedWhereNationwide, and Alabama, Arkansas, California, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, North Carolina, New Jersey, Nevada, Ohio, Pennsylvania, South Dakota, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall MCK Maximum Congruent Knee System, BIOMET FINNED PRI STEM 40MM Biomet hip joint, knee joint and shoulder joint replacement components device labeling contains incorrect GTIN (Global Trade Identification Number) codes. Class IIIFDA’s classJun 17, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 25 states named PublishedJun 17, 2015ClassClass IIIStatusTerminatedWhereNationwide, and Alabama, Arkansas, California, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, North Carolina, New Jersey, Nevada, Ohio, Pennsylvania, South Dakota, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Biomet Cobalt-Chrome Femoral Components, 32MM MOD HEAD COCR -6MM NECK Biomet hip joint, knee joint and shoulder joint replacement components device labeling contains incorrect GTIN (Global Trade Identification Number) codes. Class IIIFDA’s classJun 17, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 25 states named PublishedJun 17, 2015ClassClass IIIStatusTerminatedWhereNationwide, and Alabama, Arkansas, California, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, North Carolina, New Jersey, Nevada, Ohio, Pennsylvania, South Dakota, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Edwards Lifesciences IntraClude Intra-Aortic Occlusion Device Potential device damage on the strain relief near the hub area, which may result in blood leakage. Class IIFDA’s classJun 17, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 33 states named PublishedJun 17, 2015ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Kentucky, Louisiana, Massachusetts, Maine, Michigan, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall MX 16 Slice (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and… The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. Class IIFDA’s classJun 17, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJun 17, 2015ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia and Puerto Rico named
- Medical device recall MX 16 Slice Phase II (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems… The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. Class IIFDA’s classJun 17, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJun 17, 2015ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia and Puerto Rico named
- Medical device recall Brilliance CT 64 channel with Essence, Technology (Uninterruptible Power Supply (UPS) accessory devices)… The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. Class IIFDA’s classJun 17, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJun 17, 2015ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia and Puerto Rico named
- Medical device recall Brilliance CT 40 - Slices (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray… The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. Class IIFDA’s classJun 17, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJun 17, 2015ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia and Puerto Rico named
- Medical device recall Brilliance CT 40 - Slices(Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray… The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. Class IIFDA’s classJun 17, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJun 17, 2015ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia and Puerto Rico named
- Medical device recall Brilliance CT Big Bore Radiology (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography… The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. Class IIFDA’s classJun 17, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJun 17, 2015ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia and Puerto Rico named
Nothing matches all of these.
Remove a filter to see more. Each one is a fact FDA’s record publishes, so a recall can be left out because its record is silent on it.
Source:
FDA, Device recall enforcement reports. Released Nov 3, 2026. Updated weekly.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.”
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