GE Healthcare Advantx, Innova2000, Innova3100, Innova4100, Innova2100IQ, Innova3100IQ, and Innova4100IQ…
Medical device recall Z-0947-2013. Published in FDA’s Enforcement Report on Mar 20, 2013.
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 20, 2013. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 36 states named
- 297 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?
A locking nut might loosen out of the overhead Video Monitor Suspension yoke affecting Advantx, Innova 2000, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100, and Innova 4100IQ Cardiovascular X-ray imaging systems.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
GE Healthcare Advantx, Innova2000, Innova3100, Innova4100, Innova2100IQ, Innova3100IQ, and Innova4100IQ equipped with Video Monitor Suspension Cardiovascular X-ray imaging systems. Model numbers 2236709, 2353620 ,2223039-2, and 2270677-2.
297, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
INNOVA 41001Q 00000000609MC8 00000000605MC6 00000000535MC5 00000000225MC3 00000000226MC1 00000000463MC0 00000000223MC8 00000000377MC2 00000000816MC9 00000000841MC7 00000000469MC7 00000000228MC7 00000000830MC0 00000001258MC3 00000000937MC3…
Every code shown here, 1,998 characters
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…
FDA’s list runs to 4,540 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, AZ, CA, CO, CT, FL, GA, IL, IN, IA, KS, KY, ME, MD, MA, MN, MS,MO, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, SC, TN, TX, UT , VA, WA, WV, WI and the countries of VENEZUELA, UNITED KINGDOM, TURKEY, THAILAND, TAIWAN, SPAIN, SAUDI ARABIA, RUSSIAN FEDERATION, PORTUGAL, POLAND, NORWAY, NIGERIA, NICARAGUA, MOROCCO, MALTA, LEBANON, KAZAKHSTAN, JAPAN, ITALY, INDONESIA, INDIA, HUNGARY, GREECE, FRANCE, EGYPT, CHINA, CANADA, BRAZIL, BELGIUM, and NEW ZEALAND.
The states and territories these words name
36 states and territories.
Every one of them
- Alabama
- Arizona
- California
- Colorado
- Connecticut
- Florida
- Georgia
- Iowa
- Illinois
- Indiana
- Kansas
- Kentucky
- Massachusetts
- Maryland
- Maine
- Minnesota
- Missouri
- Mississippi
- North Carolina
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- South Carolina
- Tennessee
- Texas
- Utah
- Virginia
- Washington
- Wisconsin
- West Virginia
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 Jan 21, 2013.
- FDA classified it on Mar 13, 2013.
- FDA’s Enforcement Report published it on Mar 20, 2013.
- FDA terminated it on Jan 16, 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 4,540 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.