Medical devices, 2013: every recall, from FDA

Medical device recall B-CrossLaps/serum (B-CTx in serum) Roche Diagnostics internal investigations in R&D have shown that the claims for biotin interference and the sample stability given in the Elecsys ¿-CrossLaps… Class IIFDA’s classJul 24, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 21 states named PublishedJul 24, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, New York, Ohio, Pennsylvania, Texas, Virginia, Vermont and Washington named

Medical device recall 27023WU Balloon Catheter, 3 Fr., 2/pkg, sterile, contains latex Karl Storz Endoscopy-America has initiated the recall of the 27023WU Balloon Catheter because the packaging may be compromised, and therefore the sterility of… Class IIFDA’s classJul 24, 2013in FDA’s Enforcement Report5 statesnamed in where it went PublishedJul 24, 2013ClassClass IIStatusTerminatedWhereArizona, Florida, Illinois, Indiana and Texas

Medical device recall Safety Lancets - Odyssey, Button Activated Lancets were not sterilized within the dose range established by sterilization validation. Class IIFDA’s classJul 24, 2013in FDA’s Enforcement ReportGeorgiathe one state its words name PublishedJul 24, 2013ClassClass IIStatusTerminatedWhereGeorgia

Medical device recall CDI Blood Parameter Monitoring System 500 with Arterial and Venous blood parameter modules and… Terumo discovered through its own testing that CDI 500 Blood Parameter Monitoring System software contains inaccuracies associated with a software algorithm,… Class IIFDA’s classJul 24, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedJul 24, 2013ClassClass 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 Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named

Medical device recall CDI Blood Parameter Monitoring System 500 with Arterial blood parameter modules and Hematocrit/Saturation… Terumo discovered through its own testing that CDI 500 Blood Parameter Monitoring System software contains inaccuracies associated with a software algorithm,… Class IIFDA’s classJul 24, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedJul 24, 2013ClassClass 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 Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named

Medical device recall CDI Blood Parameter Monitoring System 500 with Arterial and Venous blood parameter modules Terumo discovered through its own testing that CDI 500 Blood Parameter Monitoring System software contains unused (turned off) accuracy correction factors for… Class IIFDA’s classJul 24, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedJul 24, 2013ClassClass 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 Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named

Medical device recall CDI Blood Parameter Monitoring System 500 with Arterial blood parameter module Terumo discovered through its own testing that CDI 500 Blood Parameter Monitoring System software contains inaccuracies associated with a software algorithm,… Class IIFDA’s classJul 24, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedJul 24, 2013ClassClass 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 Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named

Medical device recall CDI Blood Parameter Monitoring System 500 with Venous blood parameter module Terumo discovered through its own testing that CDI 500 Blood Parameter Monitoring System software contains inaccuracies associated with a software algorithm,… Class IIFDA’s classJul 24, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedJul 24, 2013ClassClass 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 Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named

Medical device recall Various types of Fetal Bovine Serum Bovine sourced Animal Sera for in-vitro diagnostic device and as a growth… Current product labeling band data sheets state that FBS Pharma Grade and FBS/FBS Native are pure Fetal Bovine Serum (FBS). Class IIFDA’s classJul 24, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 24, 2013ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Integra PANTA Arthrodesis Nail System As a result of the investigation into an adverse trend of complaints for reports of misalignment of the calcaneal or tibial screws during use of the Panta Nail… Class IIFDA’s classJul 24, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 24, 2013ClassClass IIStatusTerminatedWhereNationwide

Medical device recall KRD1 PedFuse Rods One of the rods in each of two test constructs did not meet fatigue requirement as outlined in ASTM F1717-04 dynamic compression testing 5 million cycles. Class IIFDA’s classJul 24, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 24, 2013ClassClass IIStatusTerminatedWhereNationwide, and Texas named

Medical device recall Eon - 3701 (Wall Charger) and 3711 (Portable Charger) St. Class IIFDA’s classJul 24, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 24, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named

Medical device recall Eon Mini - 3721 (Charger) St. Class IIFDA’s classJul 24, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 24, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named

Medical device recall Stryker TPS Universal Driver The safety margin values detailed in the Engineering Design were entered incorrectly into the programming software. Class IIFDA’s classJul 24, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedJul 24, 2013ClassClass IIStatusTerminatedWhereNationwide, and Arizona, Florida, Georgia, North Carolina, New York, South Carolina, Texas and Virginia named

Medical device recall CORE Universal Driver The safety margin values detailed in the Engineering Design were entered incorrectly into the programming software. Class IIFDA’s classJul 24, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedJul 24, 2013ClassClass IIStatusTerminatedWhereNationwide, and Arizona, Florida, Georgia, North Carolina, New York, South Carolina, Texas and Virginia named

Medical device recall RemB Electric Universal Driver The safety margin values detailed in the Engineering Design were entered incorrectly into the programming software. Class IIFDA’s classJul 24, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedJul 24, 2013ClassClass IIStatusTerminatedWhereNationwide, and Arizona, Florida, Georgia, North Carolina, New York, South Carolina, Texas and Virginia named

Medical device recall TDHistology/Cytology Classification name: Calculator/data processing module for clinical use A recall was initiated by Technidata because use of symbols (less than or equal to or greater than or equal to or any other symbol) in Microsoft Word reports… Class IIIFDA’s classJul 24, 2013in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedJul 24, 2013ClassClass IIIStatusTerminatedWhereCalifornia

Medical device recall Polarizer D Fixed w/Rotating Red 1 lambda plate Carl Zeiss Microscopy, LLC is recalling the Polarizer D component used in All upright ZEISS microscopes (Axio Imager, Axio Scope.A1, Axio Lab.A1) due to… Class IIFDA’s classJul 24, 2013in FDA’s Enforcement Report6 statesnamed in where it went PublishedJul 24, 2013ClassClass IIStatusTerminatedWhereFlorida, Georgia, Michigan, New York, South Dakota and Texas

Medical device recall Multi Vector Distractor Pin Holding Clamp, limited bone stock The holding clamp is part of the Multi Vector… Synthes is initiating a voluntary Medical Device removal for specified part numbers and lot numbers of the Mutis Vector Distractor Pin Holding clamp, limited… Class IIFDA’s classJul 24, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJul 24, 2013ClassClass IIStatusTerminatedWhereNationwide, and Massachusetts, Minnesota, New York, South Carolina, Texas, Utah and Virginia named

Medical device recall nanoFLEX CC4204A Intraocular Lens Correct aphakia in persons 60 years of age or older in whom a cataractous… STAAR Surgical Company is recalling a limited number of nanoFLEX CC4204A and Afinity CQ2015A intraocular lenses due to the potential presence of glass… Class IIFDA’s classJul 24, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedJul 24, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Wisconsin and West Virginia named

Medical device recall Afinity CQ2015A Intraocular Lens The visual correction of aphakia in persons 60 years of age or older in whom… STAAR Surgical Company is recalling a limited number of nanoFLEX CC4204A and Afinity CQ2015A intraocular lenses due to the potential presence of glass… Class IIFDA’s classJul 24, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedJul 24, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Wisconsin and West Virginia named

Medical device recall Alair Bronchial Thermoplasty Catheter, Bronchial Thermoplasty System Boston Scientific has discovered an inconsistent “Use By” expiration date on a single lot/batch of Alair Bronchial Thermoplasty Catheters. Class IIFDA’s classJul 24, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJul 24, 2013ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Iowa, Idaho, Michigan, Oklahoma and Washington named

Medical device recall Edwards Lifesciences Suction Wand, models S099 and S0998B Suction wands are intended for hand held use and… Edwards is recalling certain lots of Rigid Suction Wands because they discovered plastic particulate inside the sterile pouch and within the internal diam… Class IIFDA’s classJul 24, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 24, 2013ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Siemens AXIOM Artis zee/zeego systems equipped with generator A100 Plus Product Usage: Angiographic x-ray… During the course of product monitoring, Siemens became aware of a tolerance problem in the power supply of the generator control above a specific value, thus,… Class IIFDA’s classJul 24, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 16 states named PublishedJul 24, 2013ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Florida, Iowa, Illinois, Indiana, Massachusetts, Maryland, Michigan, North Carolina, New York, Pennsylvania, Puerto Rico, Texas, Virginia and Washington named

Medical device recall LifeShield; Sterile; Rx only; List No. 19666-28; SYMBIQ PUMP SET, CONVERTIBLE PIN, PIGGYBACK, 2 CLAVES PORTS… Hospira has received reports of customers experiencing air-in-line alarms related to administration sets that have a drip chamber with a ball valve. Class IIFDA’s classJul 24, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedJul 24, 2013ClassClass IIStatusTerminatedWhereNationwide, and Iowa, Illinois, Minnesota, South Dakota and Washington named

Medical device recall ExactaMix 1200 and 2400 Compounders Baxter Healthcare is recalling certain ExactaMix automated compounding devices due to the complementary metal oxide semi-conductor battery failure resulting in… Class IIFDA’s classJul 24, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 24, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named

Medical device recall Hydra Vision DR 60/80 System, Models 700539 and 700540, Liebel-Flarshiem Company A complaint was received in which a hospital physicist indicated the dosage was too high on the HUT system. Class IIFDA’s classJul 24, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJul 24, 2013ClassClass IIStatusTerminatedWhereNationwide, and Arizona, Colorado, Connecticut, Hawaii, Kansas, Kentucky and Tennessee named

Medical device recall TOSHIBA Kalare Diagnostic X-Ray System K110785 Firm initiated recall because when radiographic conditions with the small focus are set and the radiography ready switch is held down, the large focus is also… Class IIFDA’s classJul 17, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 17, 2013ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Tracoe Mini 3.0mm Tube, for pediatric use The pediatric tracheostomy tubes were mislabeled as the smaller infant tracheostomy tubes. FDA Class I, its most serious class Class IFDA’s classJul 17, 2013in FDA’s Enforcement Report2 statesnamed in where it went PublishedJul 17, 2013ClassClass IStatusTerminatedWhereAlabama and Kentucky

Medical device recall Medtronic MiniMed Paradigm Insulin Infusion Sets The Paradigm infusion sets are intended for use with… Medtronic is recalling the Medtronic MiniMed Paradigm Medtronic is recalling the Medtronic MiniMed Paradigm Insulin Infusion sets because of a potential safety… FDA Class I, its most serious class Class IFDA’s classJul 17, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 17, 2013ClassClass IStatusTerminatedWhereNationwide

Medical device recall Cardio Medical Products, Inc Covidien received customer reports of Arcing/Sparking on the defibrillation electrode leadwire which may affect Cardio Medical Products Inc. Class IIFDA’s classJul 17, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 17, 2013ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Sovereign¿ Compact Phacoemulsification System, v 5.3 Abbott Medical Optics Inc. Class IIFDA’s classJul 17, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 17, 2013ClassClass IIStatusTerminatedWhereNationwide

Medical device recall RigiflexTM 11 Single-Use Achalasia Balloon Dilator, Material Number (UPN) M00554510 Product Usage: The Boston… Product labeled with incorrect expiration date. Class IIIFDA’s classJul 17, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedJul 17, 2013ClassClass IIIStatusTerminatedWhereNationwide, and California, Maryland, Nebraska, New Jersey, New York, Ohio, Pennsylvania, Puerto Rico, Texas and Virginia named

Medical device recall NephroMax high Pressure Nephrostomy Balloon Catheter Incorrect sized renal sheath was packaged with the NephroMax high pressure nephrostomy Balloon Catheter. Class IIFDA’s classJul 17, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJul 17, 2013ClassClass IIStatusTerminatedWhereNationwide, and Illinois, Massachusetts, Maryland, Michigan, New Jersey, New York and Ohio named

Medical device recall NephroMax high Pressure nephrostomy Balloon Catheter Kit Incorrect sized renal sheath was packaged with the NephroMax high pressure nephrostomy Balloon Catheter. Class IIFDA’s classJul 17, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJul 17, 2013ClassClass IIStatusTerminatedWhereNationwide, and Illinois, Massachusetts, Maryland, Michigan, New Jersey, New York and Ohio named

Medical device recall Fresenius Liberty Cycler Set Single Conn./Ext DL Product Number: 050-87216 Automated Peritoneal Dialysis… Cassette may leak during set up or during peritoneal dialysis treatment Class IIFDA’s classJul 17, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 17, 2013ClassClass IIStatusTerminatedWhereNationwide

Medical device recall AngioDynamics RITA Main Cable, 9 Pin to 14 Pin The RITA Main Cable product contains the incorrect Instructions for Use. Class IIFDA’s classJul 17, 2013in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 17, 2013ClassClass IIStatusTerminatedWhereNo state named

Medical device recall Bigliani/Flatow¿ The Complete Shoulder Solution, Humeral Stem Provisional 12mm x 170mm This reusable trial… The firm is initiating a removal of one lot of the Bigliani/Flatow Humeral Provisional Stem (00-4301-012-17, lot 62283991) as the stems manufactured under the… Class IIFDA’s classJul 17, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJul 17, 2013ClassClass IIStatusTerminatedWhereNationwide, and Illinois and Missouri named

Medical device recall Baxter’s elastomeric infusion pumps are non-electronic, ambulatory, disposable devices that deliver… There are reported incidents of leakage on the INFUSOR and FOLFUSOR pumps at the connection of the blue winged cap and the distal male Luer. Class IIFDA’s classJul 17, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 17, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named

Medical device recall ***REF C7120***APEX Arthroscopy Tubing Set Conmed Linvatec received complaints that their products C7120 APEX Arthroscopy Tubing Set, One Connection and C7122 APEX Arthroscopy Tubing Set, Two… Class IIFDA’s classJul 17, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 20 states named PublishedJul 17, 2013ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, California, Florida, Georgia, Illinois, Indiana, Kansas, Missouri, North Carolina, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas, Utah, Virginia and Wisconsin named

Medical device recall ***REF C7122***QTY 1***APEX Arthroscopy Tubing Set Conmed Linvatec received complaints that their products C7120 APEX Arthroscopy Tubing Set, One Connection and C7122 APEX Arthroscopy Tubing Set, Two… Class IIFDA’s classJul 17, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 20 states named PublishedJul 17, 2013ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, California, Florida, Georgia, Illinois, Indiana, Kansas, Missouri, North Carolina, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas, Utah, Virginia and Wisconsin named

Medical device recall Four Lead TUR irrigation Set, for use with UROMATIC Plastic Containers A firm’s internal investigation led to the discovery of pinholes in the packaging of the products. Class IIFDA’s classJul 17, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 17, 2013ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Two Lead Arthroscopic Irrigation Set, for use with ARTHROMATIC Plastic Containers A firm’s internal investigation led to the discovery of pinholes in the packaging of the products. Class IIFDA’s classJul 17, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 17, 2013ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Four Lead Arthroscopic Irrigation Set, for use with ARTHROMATIC Plastic Containers A firm’s internal investigation led to the discovery of pinholes in the packaging of the products. Class IIFDA’s classJul 17, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 17, 2013ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Integra Hallu-Fix cannulated screw driver (model number P/N 129733ND) and cannulated screwdriver tip (model… The firm has received numerous complaints of the cannulated screw driver tip breaking during surgery. Class IIFDA’s classJul 17, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedJul 17, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia and Washington named

Medical device recall da Vinci Si Surgeon Side Cart Factory testing on da Vinci Si Surgical Systems may not be in compliance with UL Standards as one of the testing devices was found to be working incorrectly. Class IIFDA’s classJul 17, 2013in FDA’s Enforcement Report10 statesnamed in where it went PublishedJul 17, 2013ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Florida, Hawaii, Montana, New York, Texas, Utah and Washington

Medical devices, 2013

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