Discovery MR450 The systems are whole body magnetic resonance scanners designed to support high resolution,…
Medical device recall Z-1188-2017. Published in FDA’s Enforcement Report on Feb 22, 2017.
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 Feb 22, 2017. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 10 states named
- 60 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?
Potential safety issue with the patient bore heating on the Discovery MR450 narrow bore 1.5T MRI. In the event of a RF component failure, typically happening after extended system use, a small area on the bore surface may become warmer than normal. If this happens in an area where there is patient contact with the bore, and proper padding is not used, it may cause a serious burn.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Discovery MR450 The systems are whole body magnetic resonance scanners designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps. and/or spectra, dynamic images of the structures and/or functions of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate. blood vessels, and musculoskeletal regions of the body.
60, 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 00001106XF509E 209225VC450 00001106XF50A6 858939MR4 000000000R7216 858939MR3 000000000R2645 202715MR2 00000842BD50C2 202476MR1 000000000R7025 217383CMR5 00000944BD6155 MR129036 101BD66B6 573884MRI…
Every code shown here, 1,543 characters
Mfg. Lot or Serial # System ID 00001106XF509E 209225VC450 00001106XF50A6 858939MR4 000000000R7216 858939MR3 000000000R2645 202715MR2 00000842BD50C2 202476MR1 000000000R7025 217383CMR5 00000944BD6155 MR129036 101BD66B6 573884MRI 00000945BD6182 417COXMR1 000000000R2768 HSSFMR450 00001009BD65C1 HSS75MR450 00000944BD6166 803434MRI 00000298722MR0 803434MR2 00000300039MR5 832522MR2 Not Available 713566SMITH1 1106xf508e 713566SMITH3 00000296429MR4 281364MR2 00000833BD4AE7 920830MR450 00000933BD5DF8 304256MR2 00000294451MR0 030020MR03 000000000R7320 403541MR1 00000944BD616B 403955MR1 000000000R7149 250727MR2 Not Available 905522MR2 00001101XF5028 514281MR450 00000297813MR8 CS1006MR04 00000294548MR3 DK1083MR06 00000294397MR5 FI1128MR01 00000295485MR7 FI1052MR01 00000296032MR6 A2032112 00000295847MR8 M4182438 00000293919MR7 M206565701 00000294575MR6 M40330108 00000298332MR8 RMUE01MR04 0002001-0917-3 A5127236 00000304354MR4 A5808528 00000296820MR4 A5624132 00000297807MR0 D5354206 00000293603MR7 RTD0127 DUMFMI60898001 NO1017MR03 00000297987MR0 NO1009MR02 00000296493MR0 PL1539MR01 00000300882MR8 SA1058MR02 00000296613MR3 SA1011MR03 00000299452MR3 CPZ43620 00000303993MR0 M001MR01 00000293000MR6 A010MR06 00000293920MR5 N002MR02 00000303992MR2 541010MR03 00000300849MR7 0853270113 00000292973MR5 00242MRS02 00000293206MR9 70001MRS09 00000298041MR5 05217MRS02 00000293642MR5 10448MRS02 00000293724MR1 10050MRS03 00000299340MR0 00010MRS01 00000295709MR0 00200MRS04 00000294967MR5 00100MRS01 00000296514MR3 00105MRS02 00000300689MR7 2948529MR
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 states of: CA, DC, IL, MN, MO, NY, SC, TX, WI, WV; and countries of: Canada, Czech Republic, Denmark, Finland, France, Germany, Italy, Netherlands, Norway, Poland, Saudi Arabia, Spain, Sweden, Switzerland, Taiwan, United Kingdom, and Uruguay.
The states and territories these words name
- California
- District of Columbia
- Illinois
- Minnesota
- Missouri
- New York
- South Carolina
- Texas
- Wisconsin
- West Virginia
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 Jan 20, 2017.
- FDA classified it on Feb 10, 2017.
- FDA’s Enforcement Report published it on Feb 22, 2017.
- FDA terminated it on Sep 24, 2019.
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.”
- 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.