FDA Medical devices recall ·
SIGNA Creator, SIGNA Explorer, NMRI systems recall
- Recall number
- Z-1239-2025
- Date
- (initiated January 31, 2025)
- Company / brand
- GE Healthcare (China) Co., Ltd.
1F-5F BLD 1, No.1 Tongji South Road, Beijing Economic-Technological Development Area, Beijing, N/A, China - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 2538
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
SIGNA Creator, SIGNA Explorer, NMRI systems
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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
Distribution
Domestic US distribution nationwide. International distribution worldwide.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1239-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.