GE Healthcare, GE 1.5T SIGNA HDe MR SYSTEM
Medical device recall Z-1208-2013. Published in FDA’s Enforcement Report on May 8, 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 May 8, 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 2 states named
- 822 (154 US; 668 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 recently become aware of a Reformat Image Flip Issue associated with GE MR Products. The axial and coronal reformatted images from a sagittal 3D series (such as with applications of FSPGR-3D T1, BRAVO T1, or CUBE T1) of over 126 slices may display a left-to-right image flip . In addition, the acquired sagittal images may be annotated with left-right location annotation revers
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
GE Healthcare, GE 1.5T SIGNA HDe MR SYSTEM. Indicated for use as a diagnostic imaging device.
822 (154 US; 668 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 # 00000004984YR1 00000005068YR2 00000005079YR9 00000005080YR7 00000005081YR5 00000005648YR1 00000005656YR4 00000005659YR8 00000005664YR8 00000006155YR6 00000006157YR2 00000006172YR1 00000006176YR2 00000006177YR0…
Every code shown here, 2,000 characters
Mfg Lot or Serial # 00000004984YR1 00000005068YR2 00000005079YR9 00000005080YR7 00000005081YR5 00000005648YR1 00000005656YR4 00000005659YR8 00000005664YR8 00000006155YR6 00000006157YR2 00000006172YR1 00000006176YR2 00000006177YR0 00000006188YR7 00000006194YR5 00000006198YR6 00000006200YR0 00000006204YR2 00000006514YR4 00000006515YR1 00000006516YR9 00000006519YR3 00000006522YR7 00000006525YR0 00000006528YR4 00000006532YR6 00000006535YR9 00000006538YR3 00000006544YR1 00000007947YR5 00000007954YR1 00000007969YR9 00000007970YR7 00000007971YR5 00000008692YR6 00000008698YR3 00000008699YR1 00000008701YR5 00000008703YR1 00000008709YR8 00000008715YR5 00000008716YR3 00000008720YR5 00000008726YR2 00000008727YR0 00000008728YR8 00000008729YR6 00000008732YR0 00000008734YR6 00000009833YR5 00000010024YR8 00000010025YR5 00000010114YR7 00000010578YR3 00000010580YR9 00000010583YR3 00000010686YR4 00000010794YR6 00000010795YR3 00000010830YR8 00000010831YR6 00000010834YR0 00000010856YR3 00000010863YR9 00000011210YR2 00000011428YR0 00000011429YR8 00000011495YR9 00000011499YR1 00000011637YR6 00000011648YR3 00000011650YR9 00000011669YR9 00000011686YR3 00000011826YR5 00000011829YR9 00000011830YR7 00000011842YR2 00000012085YR7 00000012098YR0 00000012099YR8 00000012100YR4 00000012102YR0 00000012142YR6 00000012172YR3 00000012206YR9 00000012207YR7 00000012221YR8 00000012227YR5 00000012286YR1 00000012287YR9 00000012289YR5 00000012330YR7 00000012393YR5 00000012434YR7 00000012435YR4 00000012503YR9 00000012507YR0 00000012576YR5 00000012651YR6 00000012652YR4 00000012727YR4 00000012728YR2 00000012755YR5 00000012756YR3 00000012818YR1 00000012820YR7 00000012940YR3 00000012943YR7 00000012988YR2 00000012992YR4 00000012994YR0 00000012995YR7 00000013056YR7 00000013061YR7 00000013177YR1 00000013180YR5 00000013185YR4 00000013239YR9 00000013241YR5 00000013246YR4 00000013301YR7 00000013306YR6 00000013310YR8 00000013375YR1 00000013379YR3 00000013384YR3 00000013385YR0 00000013399YR1 00000013453YR6 00000013799YR2…
FDA’s list runs to 12,349 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 DC and Puerto Rico, excluding the state of RI and the countries of Yugoslavia YEMEN Viet Nam Venezuela Uzbekistan Uruguay United Arab Emirates Tunisia Thailand Tanzania Taiwan Turkey Syria Switzerland Sweden Spain South Korea South Africa Slovenia Slovakia Singapore Saudi Arabia Russia Romania Reunion Qatar Portugal Poland Philippines Peru Pakistan Paraguay Philippines Oman Norway Nigeria New Zealand Netherlands Morocco Mexico Martinique Malaysia Macedonia Mauritania Luxembourg Lithuania Libya Lebanon Latvia Kuwait Kenya Korea Korea (Republic Of [South] Korea) KUWAIT Kazakhstan Jordan Japan Jamaica Italy Israel Ireland Iran Iraq Indonesia India Hungary Hong Kong Honduras Guadeloupe Greece Germany Georgia, Republic of French Polynesia France Finland Estonia Ecuador Egypt Denmark Dominican Republic Czech Republic Croatia Colombia China Chile Canada Bulgaria Brazil Bosnia And Herzegovina Belgium Belarus Barbados Bahrain Austria Australia Argentina Arab Emirates Algeria and United Kingdom.
The states and territories these words name
- District of Columbia
- Puerto Rico
They leave out Rhode Island.
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 Jun 8, 2012.
- FDA classified it on May 1, 2013.
- FDA’s Enforcement Report published it on May 8, 2013.
- FDA terminated it on Nov 3, 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 12,349 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.