FDA Medical devices recall ·
SIGNA MR355, SIGNA MR360, NMRI system recall
- Recall number
- Z-1242-2025
- 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
- 241
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
SIGNA MR355, SIGNA MR360, NMRI system
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. SIGNA MR355 A. UDI-DI 00840682144407 System IDs 082427010189 082427010193 082427010195 082427010200 082427010202 082427010205 082427010207 082427010208 082427010209 082427010210 082427020099 082427020120 082427020123 082427020127 082427030181 082427030194 082427030199 082427030205 082427030210 082427030213 082427030217 082427030221 082427030228 082427040273 082427040294 082427040303 082427040307 082427040316 082427040318 082427040323 082427060097 082427070236 082427070240 082427070244 082427070247 082427070255 082427070257 082427070279 082427070285 082427070299 082427070309 082427070312 082427070313 082427070316 082427070327 082427070330 082427070335 082427070339 082427070343 082427070344 082427070348 082427080113 082427080116 082427080118 082427080133 082427080135 082427080137 082427090359 082427090474 082427100436 082427100460 082427100461 082427100466 082427100481 082427100500 082427100506 082427110098 082427110106 082427110125 082427110126 082427110147 082427110153 082427120294 082427120297 082427120306 082427120315 082427120332 082427120336 082427120339 082427120348 082427120362 082427120367 082427120374 082427130130 082427140315 082427140332 082427160293 082427160303 082427160311 082427160312 082427160316 082427160327 082427160333 082427160341 082427160351 082427160352 082427160359 082427160364 082427160366 082427160367 082427160369 082427160374 082427160394 082427160397 082427160406 082427160416 082427160419 082427160421 082427170028 082427170032 082427180074 082427
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-1242-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.