FDA Device recall Z-1242-2025
SIGNA MR355, SIGNA MR360, NMRI system
- FDA Device
- Class II
- ongoing
- Published 2025-03-05
On 2025-03-05 the FDA classified a Class II recall of SIGNA MR355, SIGNA MR360, NMRI system by Ge Healthcare China, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1242-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-01-31 |
| Published | 2025-03-05 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Ge Healthcare China |
| Distribution | US |
Product
SIGNA MR355, SIGNA MR360, NMRI system
Reason
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.
Identifiers
| code_info | 1. SIGNA MR355 A. UDI-DI 00840682144407 System IDs 082427010189 082427010193 082427010195 082427010200 082427010202 082…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1242-2025%22
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