GE Healthcare, Discovery MR750, Discovery 450, Optima 450W (with and without GEM), Signa HDx, Signa HDxt,…
Medical device recall Z-1207-2013. 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
- 4338 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, Discovery MR750, Discovery 450, Optima 450W (with and without GEM), Signa HDx, Signa HDxt, Signa HDi, Signa Vibrant. Indicated for use as a diagnostic imaging device.
4338, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Mfg Lot or Serial # 00000029854MR5 00000030086MR1 00000030154MR0 00000235678MR0 00000235678MR0 00000288408MR8 00000289961MR5 00000290137MR9 00000292634MR3 00000292964MR4 00000292964MR4 00000293015MR4 00000293338MR0 00000293646MR6…
Every code shown here, 2,000 characters
Mfg Lot or Serial # 00000029854MR5 00000030086MR1 00000030154MR0 00000235678MR0 00000235678MR0 00000288408MR8 00000289961MR5 00000290137MR9 00000292634MR3 00000292964MR4 00000292964MR4 00000293015MR4 00000293338MR0 00000293646MR6 00000293874MR4 00000293918MR9 00000294018MR7 00000294057MR5 00000294098MR9 00000294280MR3 00000294472MR6 00000294494MR0 00000294556MR6 00000294576MR4 00000294643MR2 00000294665MR5 00000294718MR2 00000294913MR9 00000294953MR5 00000295024MR4 00000295092MR1 00000295112MR7 00000295134MR1 00000295215MR8 00000295228MR1 00000295241MR4 00000295506MR0 00000295904MR7 00000296014MR4 00000296046MR6 00000296070MR6 00000296096MR1 00000296097MR9 00000296171MR2 00000296226MR0 00000296228MR0 00000296307MR2 00000296369MR2 00000296418MR7 00000296429MR4 00000296461MR7 00000296462MR5 00000296469MR0 00000296512MR7 00000296517MR6 00000296573MR9 00000296595MR2 00000296602MR6 00000296626MR5 00000296640MR6 00000296821MR2 00000296829MR5 00000296840MR2 00000296860MR0 00000296888MR1 00000296894MR9 00000296908MR7 00000297006MR9 00000297134MR9 00000297147MR1 00000297355MR0 00000297374MR1 00000297387MR3 00000297469MR9 00000297493MR9 00000297624MR9 00000297649MR6 00000297833MR6 00000297880MR7 00000297891MR4 00000298050MR6 00000298083MR7 00000298181MR9 00000298247MR8 00000298248MR6 00000298249MR4 00000298283MR3 00000298310MR4 00000298334MR4 00000298386MR4 00000298387MR2 00000298399MR7 00000298474MR8 00000298494MR6 00000298512MR5 00000298535MR6 00000298537MR2 00000298552MR1 00000298573MR7 00000298574MR5 00000298580MR2 00000298591MR9 00000298655MR2 00000298656MR0 00000298675MR0 00000298677MR6 00000298722MR0 00000298727MR9 00000298738MR6 00000298834MR3 00000298861MR6 00000298869MR9 00000298870MR7 00000298889MR7 00000298901MR0 00000298907MR7 00000298908MR5 00000298932MR5 00000298943MR2 00000298959MR8 00000298981MR2 00000299141MR2 00000299160MR2 00000299161MR0 00000299171MR9 00000299172MR7 00000299173MR5 00000299181MR8 00000299199MR0 00000299200MR6 00000299213MR9 00000299230MR3…
FDA’s list runs to 64,978 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 64,978 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.