Hearth Record

GE Healthcare, Discovery MR750w

Medical device recall Z-2131-2016. Published in FDA’s Enforcement Report on Jul 13, 2016.

FDA’s own record, on accessdata.fda.gov

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 Jul 13, 2016. Copied from openFDA on Oct 20, 2026.

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.

Source:

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 patient bore heating on the Discovery MR750w. A small area on the bore surface, which is normally accessible to the patient, can get warm enough to cause a serious burn in the event the patient touches the bore and proper padding is not used. No injury has been reported to GE as a result of this issue.

Source:

FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.

Which ones are recalled?

GE Healthcare, Discovery MR750w

471 (184 US; 287 OUS), in FDA’s words.

Source:

FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.

Codes to check against yours

Mfg Lot or Serial # System ID 00001250FMM03D 9075653T 00001308FMM00B 602863MR Missing_SN_GON4205067 480342MR3 00001134FMM10E 928348MR 00001140FMM0FX RADNETMR597 N/A 530CHI750W N/A 858824MR1 00000000UA0083 408356MR1 00001204FMM058…

Every code shown here, 1,995 characters

Mfg Lot or Serial # System ID 00001250FMM03D 9075653T 00001308FMM00B 602863MR Missing_SN_GON4205067 480342MR3 00001134FMM10E 928348MR 00001140FMM0FX RADNETMR597 N/A 530CHI750W N/A 858824MR1 00000000UA0083 408356MR1 00001204FMM058 RADNETMR599 00000000UA0262 949760MR3 00000308185MR8 510449MR750W 00000000UA0075 619543HDMR4 00000000UA0118 858622HDMR1 00001204FMM052 415CB3TW 00001309FMM08B RADNETMR613 00001307FMM09Y 415UCBHMR3 1-4G33-86 805739MR3 310871MR9 310264MR2 309905MR8 RADNETMR621 00001204FMM04G 559734VIMR1 000005373011-3 RADNETMR598 N/A 720848MR4 N/A 720848MR3 311108MR5 303492MR 00001118FMM0WE 303604MR2 00001309FMM09E 720854MR 00000000UA0472 719365MR Missing_SN_GON4077136 303837MR2 309815MR9 970624MR1 310950MR1 860446MR750W 00001251FMM00R 202966MR3TW Missing_SN_GON4231312 561955MR1 00001309FMM097 386FNSBMR3T 00001308FMM042 954355MR750W 1309FMM09F 904483MR3T 00000000UA0465 305665MR750W 00001204FMM057 305461MR1 00001140FMM0FG 407SMSLMR1 00001147FMM0E5 386FHPCMR3T 00001223FMM08M 561844MR1 N/A 706787750DV 00001236FMM04Y 912819MR 00001301FMM043 671NAVYMR 00001234FMM0KL 671FHPMR750W 310330MR6 808HRAEMR750W 00001204FMM055 808545MR 00001250FMM035 808YMMR 00000306104MR1 808873MR750W 1-4GFG-928 319335MR2 310776MR0 773665SJMR2 PG75W1600017MR 312702MR750 00001250FMM02E 217876DMH3T N/A 847316MR3T 00000305089MR5 708346MR3 00000307816MR9 708346MR4 310973MR3 309655IMRI 00001309FMM094 309655MR750W N/A 815968MR 00001203FMM0VP 815395MR2 00000306062MR1 847872ZMR2 00000309665MR8 317887MR3 00001308FMM03T 317865MR4 00001308FMM006 913322MISHMRW 310253MR0 859334MR 00001221FMM06J 270798MR2 1406NMM0C2 318443MR2 00000307418MR4 225763MR2 00001236FMM051 337289MR1 1236FMM04H 337943MR1 00001251FMM01F BRIGHAM750WMR1 00001227FMM011 BOSTONMEDMR1 MISSING_SN_GON#4350388 508746MR3 00001250FMM03C VAWESTROX750W 00001309FMM085 410328MR3T 00001204FMM04U RADNETMR1652 00000306342MR7 RADNETMR1651 00001203FMM0W2 RADNETMR1635 00000303329MR7 RADNETMR1629 223355 3014643TMR Missing_SN_GON4216878 240707MR3T…

FDA’s list runs to 11,463 characters. The first part is shown; the rest is on FDA’s record.

Source:

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.

US: AK, AZ, CA, COM, CT , DC, FL, GA, GU, HI, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MO, NV, NH, NJ, NY, NC, OH,OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WY. OUS: Algeria Argentina Australia Austria Bahrain Belarus Belgium Bermuda Brazil Bulgaria Canada China Egypt France Germany Hungary India Indonesia Ireland Italy Japan Kazakhstan Korea (Republic of) Kuwait Lebanon Mexico Netherlands New Zealand Poland Qatar Romania Russia Russian Federation Saudi Arabia Singapore Spain Sweden Switzerland Taiwan Thailand Turkey United Arab Emirates United Kingdom Uruguay

The states and territories these words name

38 states and territories.

Every one of them
  • Alaska
  • Arizona
  • California
  • Connecticut
  • District of Columbia
  • Florida
  • Georgia
  • Guam
  • Hawaii
  • Iowa
  • Illinois
  • Indiana
  • Kansas
  • Kentucky
  • Louisiana
  • Massachusetts
  • Maryland
  • Maine
  • Michigan
  • Minnesota
  • Missouri
  • North Carolina
  • New Hampshire
  • New Jersey
  • Nevada
  • New York
  • Ohio
  • Oklahoma
  • Oregon
  • Pennsylvania
  • South Carolina
  • Tennessee
  • Texas
  • Utah
  • Virginia
  • Washington
  • Wisconsin
  • Wyoming

The words say it went outside the United States too.

Source:

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.

Source:

What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.

  • The firm began the recall on Jun 8, 2016.
  • FDA classified it on Jul 6, 2016.
  • FDA’s Enforcement Report published it on Jul 13, 2016.
  • FDA terminated it on Oct 4, 2018.
Source:

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.
Source:

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 11,463 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.
Source:

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.

Source:

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.

How to read a record

Four things every record does, shown on an example record made up for this guide.

An example record, made up for this guide

An example nursing home

Made up for this guide: no real place is shown

Not fully inspected in over two years (CMS flag)

11 health citations at the latest inspection cycle

The state average is 14.3.

Source:

CMS, State and US Averages and Health Deficiencies. Released Oct 28, 2026. Updated monthly.

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Every fact names its source.

Who published it, when, and how often it changes sit beside each fact, with a link to the agency’s own file.

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