GE Healthcare, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100, Innova 4100IQ Innova 2121IQ, Innova…
Medical device recall Z-1163-2014. Published in FDA’s Enforcement Report on Mar 19, 2014.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Mar 19, 2014. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 39 states named
- 257(159 US, 98 OUS) how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
GE Healthcare has become aware of a potential safety issue involving the innova systems. The Innova system can unexpectedly stop delivering X-rays after a power-on or a reset cycle which may result in the loss of real-time interventional imaging. No injuries have been reported due to this issue.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
GE Healthcare, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100, Innova 4100IQ Innova 2121IQ, Innova 3131IQ; Cardiovascular X-ray imaging systems (X-ray generator installed with Rotor V3 version and Heater V4 version boards). The Digital Fluoroscopic Imaging System is indicated for use in generating fluoroscopic images of human anatomy for diagnostic and intervention angiography procedures. It is intended to replace fluoroscopic images obtained through the image intensifier technology. This device is not intended for mammography applications. The Innova 3100 system is indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, and optionally, rotational and angiography procedures. It is intended to replace fluoroscopic images obtained through image intensifier technology. The Digital Fluoroscopic Imaging System is indicated for use in diagnostic and interventional angiographic procedures of human anatomy. It is intended to replace image intensifier fluoroscopic systems in all diagnostic or interventional procedures. This device is not intended for mammography applications. A new tilt table will support performing procedures like CO2 studies, Venography. The Digital Fluoroscopic Imaging System with Bolus Chasing option is indicated for use in generating fluoroscopic images of human anatomy for diagnostic and intervention; the option Bolus enables to perform subtraction angiography of lower limbs. This device is not intended for mammography applications. The Innova 2100-IQ system is indicated for use in generating fluoroscopic images of human anatomy for vascular angiography diagnostic and interventional procedures, and optionally, rotational angiography procedures. It is also indicated for generating fluoroscopic images of human anatomy for cardiology diagnostic and interventional procedures. It is intended to replace fluoroscopic images obtained through image intensifier technology. This device is not intended for mammography applications. For Innova 4100, Innova 4100IQ, Innova 3100, Innova 3100 IQ, Innova 2100IQ with Innova 3T Option: The Innova systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational imaging procedures. They are also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures. They are intended to replace fluoroscopic images obtained through image intensifier technology. Those devices are not intended for mammography applications. Innova CT is a software option, which reconstructs 3D volumes from Rotational Fluoroscopy acquisition to provide images that assist the physician in diagnosis, surgical planning, interventional procedures and treatment follow-up. Innova CT is intended for imaging bone and soft tissues as well as other internal body structures. Innova CT is not intended for mammography applications. For Innova 4100, Innova 4100IQ, Innova 3100, Innova 3100 IQ, Innova 2100IQ with Innova 3D or InnovaSpin option: The Innova systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational imaging procedures. They are also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures. They are intended to replace fluoroscopic images obtained through image intensifier technology. Those devices are not intended for mammography applications. Innova 3D is a software option which reconstructs 3D volumes from Rotational Fluoroscopy acquisition to assist the physician in diagnosis, surgical planning, interventional procedures and treatment follow-up. It is not intended for mammography applications. InnovaSpin is a software option that permits fast spin rotational angiography. It is not intended for mammography applications. :
257(159 US, 98 OUS), in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Mfg Lot or Serial # System ID 00000550134BU1 2035763100A 00000581573BU3 203932VA4100 00000523132BU9 205783BCL5 00000560743BU7 206598UWBP 00000446090BU3 207351YCL1 00000504213BU0 212305CATH1 00000437215BU7 214324INNOVA2 00000562417BU6…
Every code shown here, 1,999 characters
Mfg Lot or Serial # System ID 00000550134BU1 2035763100A 00000581573BU3 203932VA4100 00000523132BU9 205783BCL5 00000560743BU7 206598UWBP 00000446090BU3 207351YCL1 00000504213BU0 212305CATH1 00000437215BU7 214324INNOVA2 00000562417BU6 2198864100 00000093723VE5 229228INNOV21C 00000583484BU1 240566CATH2 00000478109BU2 251435ICV3 00000477896BU5 3016094100 00000441137BU7 3018774100 00000466659BU0 303788CL1 00000466984BU2 304424INNOVA 00000445301BU5 309691P3100 00000424103BU0 310423INNOVA1 00000579612BU3 313745IN1 00451726BU4BU8 316268INNOVAA 00000466810BU9 318449INNOVA2 00000482326BU6 3184734100 00000499386BU1 330375LAB2 00000445906BU1 334286BSP 00000551081BU3 336832MCCL6 00000464558BU6 352333CATH2 00000463833BU4 361980INNOVA2 00000427056BU7 401274IN41 00000585912BU9 404712SP11 00000585915BU2 405271P4100 00000593051BU6 405610MWC3100EP 00000449428BU2 405840OIC3100 00000541272BU1 407518EP 00000431502BU4 407518SP3 00000452126BU6 407SPECIALS 00000490443BU9 408559INV1 00000421698BU2 4103374100 00000461599BU3 410337INNOVA6 00000571721BU0 410368INNOVA1 00000442436BU2 4105434100 00000533867BU8 410554INNOVA1 00000548841BU6 410554INNOVA4 00000560325BU3 410614CV1 00000443912BU1 412623LAB3 00000454264BU3 419251LAB1 00000576989BU8 423493CL1 00000450075BU7 480821IN2 00000468193BU8 501257VALAB1 00000434782BU9 502587LAB4 FMI12204DUMM03 508383IN4100 00000581740BU8 509473RM1 00000459476BU8 5135844100 00000415698BU0 5136864100 00000479625BU6 516562INNOVA5A 00000460641BU4 516562INNOVA6 00000460969BU9 516562INNOVA7 00000441966BU9 516663INNOVA2 00000467462BU8 518525LAB1 00000467645BU8 540953INNOVA 00000513959BU7 570476INNOVA21 00000466830BU7 573256MHC 00000479758BU5 573815BCR2 00000433021BU3 573882UMC1 00000446439BU2 6012884100SP1 00000558894BU2 601376SP4100 00000437985BU5 6082634100 00000410733BU0 608324DAL 00000543076BU4 608775NOVA1 00000561529BU9 609267IN2100 00000546435BU9 609757IN3100 00000491706BU8 610250INNOVA3 00000442603BU7 614293LIBERTY2 00000563635BU2 614722INNOVA1 00000458814BU1…
FDA’s list runs to 6,875 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide Distribution - USA (nationwide) including the states of AL, AK, AZ, AR, CA, CO, CT, FL, GA, IL, IN, KS, KY, LA, ME, MD, MA, MI, MS, MO, NV, NJ, NY, NC, ND, OH, OK OR, PA, PR, RI, SC, TN, TX, UT, VA,WA,WY and WI., and the countries of ARGENTINA, AUSTRALIA, CANADA, CHINA, CZECH REPUBLIC, DENMARK, EGYPT, FINLAND, FRANCE, GERMANY, HUNGARY, INDIA, IRELAND, ITALY, JAPAN, JORDAN, REPUBLIC OF KOREA, MALAYSIA, MEXICO, NEW ZEALAND, NORWAY, PHILIPPINES, POLAND, RUSSIA, SAUDI ARABIA, SPAIN, SRI LANKA, TURKEY and UNITED KINGDOM.
The states and territories these words name
39 states and territories.
Every one of them
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Florida
- Georgia
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Missouri
- Mississippi
- North Carolina
- North Dakota
- New Jersey
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Puerto Rico
- Rhode Island
- South Carolina
- Tennessee
- Texas
- Utah
- Virginia
- Washington
- Wisconsin
- Wyoming
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Dec 11, 2013.
- FDA classified it on Mar 10, 2014.
- FDA’s Enforcement Report published it on Mar 19, 2014.
- FDA terminated it on Jul 29, 2014.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- GE Healthcare, LLC, of Waukesha, WI.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 6,875 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
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.” Copied on Oct 20, 2026.