GE Healthcare, Discovery MR750w 3.0T
Medical device recall Z-0254-2016. Published in FDA’s Enforcement Report on Nov 18, 2015.
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 Nov 18, 2015. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 3 states named
- 756 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?
When performing head or neck scans, the currently displayed SAR values could be lower than the actual SAR in the head as predicted by SAR modeling. The predicted HEAD SAR value from the modeling suggests the actual SAR in the head could exceed IEC60601-2-33 limit of 3.2 W/kg for some scans.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
GE Healthcare, Discovery MR750w 3.0T. Product Usage: The Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T and the Optima MR450w 1.5T Systems are whole body magnetic resonance scanners for diagnostic imaging.
756, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
00000302690MR3 HCIMR1805 00000290502MR4 MR129030 00000291489MR3 415723SHMR10 00000294472MR6 650723SSMR1 00000290704MR6 650723SSMR2 00000289310MR5 HSSMR750 00000289961MR5 SINAI750MR 00000290457MR1 608263MR6 00000290050MR4 281276MR750…
Every code shown here, 1,995 characters
00000302690MR3 HCIMR1805 00000290502MR4 MR129030 00000291489MR3 415723SHMR10 00000294472MR6 650723SSMR1 00000290704MR6 650723SSMR2 00000289310MR5 HSSMR750 00000289961MR5 SINAI750MR 00000290457MR1 608263MR6 00000290050MR4 281276MR750 00000290659MR2 610740MR3 00000290202MR1 415723CHMR2 290957MR0 608HERIMR 00000290636MR0 MR129034 00000290137MR9 650723NCMR1 00000289309MR7 650723NCMR2 00000291397MR8 517353DVMR 00000291363MR0 616391DVMR 00000291980MR1 704384DVMR 00000292367MR0 INSIGHTMR3228 00000292471MR0 804675VA3T 00000288408MR8 608WAISMR 00000292634MR3 2486613TMR 00000288907MR9 MR129035 00000292431MR4 541CMRIMR 00000290773MR1 415L3TMR2 00000291877MR9 415L3TMR1 00000291185MR7 MSK65MR1 00000292528MR7 608WIMRMR2 00000291244MR2 MSK65MR2 00000293338MR0 206CH750MR 00000291464MR6 217528MR1 00000292843MR0 217788MR3 00000294556MR6 540665MR3T 00000293261MR4 415OI3TMR 00000293015MR4 910907WAMR1 00000292678MR0 919684MR5 00000293561MR7 405752I3T 00000293874MR4 HSSGMR750 00000294018MR7 903525MR750 00000000000641 434UVAMR 00000294057MR5 281274MR1 00000294576MR4 602830MR3 00000294698MR6 812485MR3 00000294665MR5 480768MR2 00000294718MR2 715838MR3T 00000295112MR7 801377MR3 00000295024MR4 207945MR750 00000295111MR9 703391MR2 00000294953MR5 7579533T 00000295802MR3 269DVMR 00000295228MR1 6036503T 00000296046MR6 309683MNMR750 00000295904MR7 281477MR2 00000295506MR0 858822HDMR1 00000296014MR4 816932DVMR 00000296640MR6 617726MR1A2 00000296512MR7 916LST3TMR 00000296461MR7 MR129037 00000294999MR8 MSK68MR4 00000295215MR8 301295MR4 00000296602MR6 7168453T 00000296821MR2 DUPONT3T 00000294398MR3 713441MR9 00000296114MR2 713441MR8 00000297469MR9 954772MR1 00000296517MR6 615MTMR1 00000297974MR8 810235DVMR 00000297624MR9 415493VMR2 00000296908MR7 386FMR3T 00001106XF511E 202476MR3 00000298283MR3 616494DVMR 00000298591MR9 414805MR2 00000298677MR6 412647PUHMR1 00000298420MR1 6162673T750 00000298537MR2 832522MR1 00000298765MR9 9155693TMR 00000298981MR2 480425MR6 00000297374MR1 650PH3T 00000298738MR6…
FDA’s list runs to 18,653 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 - US: Nationwide including DC, PR and GU and the countries of ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BELARUS, BELGIUM, BERMUDA, BOSNIA HERZEGOVINA, BRAZIL, BULGARIA, CANADA, CHINA, CZECH REPUBLIC, DENMARK, EGYPT, ESTONIA, ETHIOPIA, FINLAND, FRANCE, GERMANY, GREECE, HONG Kong, HUNGARY, INDIA, INDONESIA, IRAN, IRELAND, ISRAEL, ITALY, JAMAICA, JAPAN, KAZAKHSTAN, REPUBLIC OF KOREA, KUWAIT, LEBANON, LUXEMBOURG, MALAYSIA, MEXICO, NETHERLANDS, NEW ZEALAND, NORWAY, PERU, POLAND, PORTUGAL, QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, SYRIA, TAIWAN, THAILAND, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY, and VENEZUELA.
The states and territories these words name
- District of Columbia
- Guam
- Puerto Rico
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 Aug 31, 2015.
- FDA classified it on Nov 9, 2015.
- FDA’s Enforcement Report published it on Nov 18, 2015.
- FDA terminated it on Sep 7, 2018.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- GE Healthcare, 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 18,653 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.