GE Healthcare, Discovery 3.0T MR750, 5148810-2, 5373011-2, 5499460-2.
Medical device recall Z-0201-2019. Published in FDA’s Enforcement Report on Oct 31, 2018.
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 Oct 31, 2018. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- 26 states named in where it went
- 356 (98 US; 258 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 potential safety issue with the 3.0T 6 Channel Flex Coil used with the 3T MR750W Surgical Suite Scanners. Coil overheating can occur when the device is used in Mode 2 setup. This could lead to a serious patient thermal injury. There have been no injuries reported as a result of this issue. UPDATE 5/27/2016: Recall has been updated to include an additional product which includes the Discovery 3.0T MR750 systems running Application Software DV24 R01, DV25 R02, or DV25.1 M3.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
GE Healthcare, Discovery 3.0T MR750, 5148810-2, 5373011-2, 5499460-2.
356 (98 US; 258 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 # System ID 000000HDMR6188 301496MR3T4 000873824-0007 82427140106 00001105XF503F ASLW750 00001026XF518E 82427180022 00001048XF500F 82427210091 00001106XF5125 82427120092 00001106XF512A 82427120097 00001106XF5105…
Every code shown here, 1,994 characters
Mfg Lot or Serial # System ID 000000HDMR6188 301496MR3T4 000873824-0007 82427140106 00001105XF503F ASLW750 00001026XF518E 82427180022 00001048XF500F 82427210091 00001106XF5125 82427120092 00001106XF512A 82427120097 00001106XF5105 82427260003 00001105XF5030 82427040143 0000000UA0199A 82427040146 00001307FMM04C 82427200058 00000005271M22 82427210118 00000000395M24 EM0003 00000000WB0792 82427200076 641 434UVAMR 00000950BD62C2 G001MR01 00000914BD5A87 910272064 00001007BD6466 910272071 00001011BD663A 910272072 00001012BD66AE MRWB0558 00001009BD65AC 82427230048 00001009BD65A1 82427210068 00001012BD6696 82427230051 00001010BD6607 600110MR01 00000952BD62F0 EG1793MR01 00000903BD55F9 M4215566 00001002BD639D M40180117 00000914BD5A86 615010MR01 00000934BD5E44 J5274809 00000905BD567C A5279314 00000926BD5D00 2806034DVR750 00001007BD6471 RU3508MR01 00000919BD5B81 SA2180MR02 00001011BD6689 E001MR02 00000848BD5326 K002MR02 00000931BD5D88 853270103 00000944BD6163 853270104 00001009BD65E7 853270109 00001011BD6639 70065MRS03 00000931BD5D89 70328MRS05 00000836BD4DB5 475290MR01 00000291244MR2 MSK65MR2 00000293015MR4 910907WAMR1 00000296461MR7 MR129037 00000297637MR1 650723PSYMR 00000293065MR9 918491MR1 00000291464MR6 217528MR1 00000289961MR5 SINAI750MR 00000290050MR4 281276MR750 00000290659MR2 610740MR3 00000291363MR0 616391DVMR 00000291980MR1 704384DVMR 00000292367MR0 INSIGHTMR3228 00000292471MR0 804675VA3T 00000292634MR3 2486613TMR 00000293874MR4 HSSGMR750 00000292431MR4 541CMRIMR 00000290773MR1 415L3TMR2 00000291877MR9 415L3TMR1 00000298591MR9 414805MR2 00000292843MR0 217788MR3 00000294556MR6 540665MR3T 00000293261MR4 415OI3TMR 00000292678MR0 919684MR5 00000293561MR7 405752I3T 00000294018MR7 903525MR750 00000294057MR5 281274MR1 00000294576MR4 602830MR3 00000294698MR6 812485MR3 00000294665MR5 480768MR2 00000294718MR2 715838MR3T 00000295112MR7 801377MR3 00000295024MR4 207945MR750 00000295111MR9 703391MR2 00000294953MR5 7579533T 00000295228MR1 6036503T 00000296046MR6 309683MNMR750…
FDA’s list runs to 8,665 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 Distribution including the states of AZ, CA, CO, IL IN, MI, MN, NY, OH, OK, SD, TX, WI, VA, DE, FL, MD, ME, MO, NC, NH, OR, PA, TN, WI, DC, PR and the countries of CANADA, CHINA, CZECH REPUBLIC, ITALY, JAPAN, NETHERLANDS, NEW ZEALAND, PORTUGAL, ROMANIA, SOUTH AFRICA, SWITZERLAND, TURKEY, SWEDEN, AUSTRALIA, BRAZIL, CZECH REPUBLIC, EGYPT, FRANCE, GERMANY, ITALY, MEXICO, RUSSIA, SAUDI ARABIA, TAIWAN, UNITED KINGDOM, INDONESIA, ESTONIA, REPUBLIC OF KOREA, POLAND, KUWAIT, SPAIN.
The states and territories these words name
26 states and territories.
Every one of them
- Arizona
- California
- Colorado
- District of Columbia
- Delaware
- Florida
- Illinois
- Indiana
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- North Carolina
- New Hampshire
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Puerto Rico
- South Dakota
- Tennessee
- Texas
- Virginia
- Wisconsin
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 Dec 7, 2015.
- FDA classified it on Oct 22, 2018.
- FDA’s Enforcement Report published it on Oct 31, 2018.
- FDA terminated it on Nov 8, 2018.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- GE Medical Systems, LLC, of Waukesha, WI.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Telephone.
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 8,665 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.