GE Healthcare, Advantage Workstation, READY View Application
Medical device recall Z-2241-2013. Published in FDA’s Enforcement Report on Sep 25, 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 Sep 25, 2013. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- 5 states named in where it went
- 318 (28 USm 290 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 that when analyzing fMRI images using the READY View application software, incorrect fMRI activation maps may be computed and displayed.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
GE Healthcare, Advantage Workstation, READY View Application. Image analysis software.
318 (28 USm 290 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 # 00000235940GE4 00000260698GE6 00000260686GE1 00000235943GE8 00000253548GE2 00000260699GE4 000000010006GS 00000L3AB501ED 00000253550GE8 00000253551GE6 00000260681GE2 00000260682GE0 00000260683GE8 00000260684GE6…
Every code shown here, 2,000 characters
Mfg Lot or Serial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…
FDA’s list runs to 4,789 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 including the states of IL, MN, NJ, NY, and VA, and the countries of ALGERIA, AUSTRALIA, BELGIUM, BRAZIL, CANADA, DENMARK, FINLAND, FRANCE, GERMANY, GUADELOUPE, INDIA, INDONESIA, ISRAEL, ITALY, JAPAN,KOREA, LATVIA, MARTINIQUE, NETHERLANDS, NORWAY, PHILIPPINES,S POLAND, REUNION, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA, SPAIN, SWEDEN SWITZERLAND, THAILAND, TUNISIA, TURKEY, UNITED KINGDOM, and VIETNAM.
The states and territories these words name
- Illinois
- Minnesota
- New Jersey
- New York
- Virginia
The words say it went outside the United States too.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
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 Mar 27, 2012.
- FDA classified it on Sep 18, 2013.
- FDA’s Enforcement Report published it on Sep 25, 2013.
- FDA terminated it on Nov 21, 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 4,789 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
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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.