SIGNA Creator, SIGNA Explorer, NMRI systems
Medical device recall Z-1239-2025. Published in FDA’s Enforcement Report on Mar 5, 2025.
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 Mar 5, 2025. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 2538 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?
For certain MR systems, a scan can be resumed following a Power Monitor trip when the “6-minute average SAR” is above the limit indicated on the “SAR Display”. The user interface may incorrectly enable a scan to proceed earlier than intended. If resumed by the operator, such a scan can result in potential excessive tissue heating, especially if the patient is in contact with a conductive material or has an implant.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
SIGNA Creator, SIGNA Explorer, NMRI systems
2538, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
1. Creator A. UDI-DI 00195278577221, System ID MR00160 MR00171 MR00189 THMR54503051 (Update 12/29/25 - New System ID MRR10626) (Update 1/28/26 - New System IDs MRR10269 850270138) (Update 2/19/26 - Addl System IDs MR00299¿ PHMRI24836517…
Every code shown here, 1,992 characters
1. Creator A. UDI-DI 00195278577221, System ID MR00160 MR00171 MR00189 THMR54503051 (Update 12/29/25 - New System ID MRR10626) (Update 1/28/26 - New System IDs MRR10269 850270138) (Update 2/19/26 - Addl System IDs MR00299¿ PHMRI24836517 12440397 13131449¿ PC0084) B. UDI-DI 00195278577238, System ID 083027026539324 5973MR0087 5973MR0091 5973MR0095 5973MR0096 5973MR0097 5973MR0100 5973MR0103 5973MR0104 5973MR0106 5973MR0107 5973MR0109 9830MR0112 9830MR0113 9830MR0114 9830MR0117 A199750201 IDMRI24467771 MR00082 MR00111 MR00120 MR00138 MR00140 MR00143 MR00152 MR00157 MR00174 MR00179 MR00180 MR00187 MR00191 MR00192 MR00195 MR00210 MR00229 MR00231 MR00236 MR00249 MR00251 MR00258 MR00263 MR00282 MRR1170 MRR1182 MRR2198 MRR2508 MRR2860 MRR2916 MRR2938 MRR3171 MRR3873A MRR3954 MRR4356 MRR4501 MRR4726 MRR493 MRR5138 MRR5332 MRR5494 MRR5684 MRR569A MRR6219 MRR673 MRR7117 MRR9626 MRYR2151 VNMRI24476142 VNMRI24513835 (Updated 12/29/25 - Additional System IDs MRR3679 , MR00322) (Updated 2/19/26 - Additional System IDs 83027280426725 83027280425025 MR00219 VNMRI24845558 THMRI25011164¿) C. UDI-DI 00840682113762, System ID 6529149 7361387 07143820 082427030212 082427040272 082427040285 082427060095 082427060119 082427070318 082427080107 082427080129 082427090384 082427090403 082427090419 082427090433 082427090434 082427090436 082427090448 082427100397 082427100418 082427110140 082427120326 082427120330 082427130173 082427160292 082427160307 082427160310 082427160318 082427160319 082427160343 082427160375 082427200201 082427200216 082427220123 082427220126 082427230245 082427230253 082427250094 082427250096 082427250122 082427290064 082427310174 0828270077 0850270635 0850270645 0850270695 0850270772 1553MR0020 1557MR0052 1573MR0064 5973MR0073 7982MR0048 A5421025 A5816111 HU1729MR01 MR00017 MR00018 MR00042 MR51028441 MRR1577 MRR192 MRRD1008 MRRD1027 MRRD1205 MRRD1331 MRRD1376 PC6242 PC6249 PC6261 PC6264 PC6273 PC6277 PC6286 PPS16207 RF1647MR01 RF3314MR01 RU1115MR01 RU2144MR01…
FDA’s list runs to 30,244 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.
Domestic US distribution nationwide. International distribution worldwide.
These words name no state.
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?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, 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 31, 2025.
- FDA classified it on Feb 27, 2025.
- FDA’s Enforcement Report published it on Mar 5, 2025.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- GE Healthcare (China) Co., Ltd., of Beijing, China.
- 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 30,244 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.