Optima MR360 MRI System (GE Healthcare) – SAR monitoring (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Optima MR360, NMRI system
Brand
GE Healthcare (China) Co., Ltd. 1F-5F BLD 1, No.1 Tongji South Road, Beijing Economic-Technological Development Area Beijing China
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
A. UDI-DI 00840682113762 System ID 0910274038 B. No UDI-DI System IDs 082427040134 082427040185 082427060043 082427070088 082427070093 082427070099 082427100174 082427100178 082427100197 082427120140 082427140095 082427220046 082427270041 082427310088 082427310092 083027288790310 0856270061 AE1373MR01 DZ1339MR03 FI1432MR01 H4678MR04 MRR9282 MRR9877 PL2059MR01 PL2433MR01 RU3338MR03 SA1056MR03 SA2191MR04 SA2253MR01 SA2352MR01 TN1008MR01 TN1241MR01 34352MRS01
GE Healthcare (China) Co., Ltd. 1F-5F BLD 1, No.1 Tongji South Road, Beijing Economic-Technological Development Area Beijing China is recalling Optima MR360, NMRI system due to 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 . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
On January 31, 2025, the firm notified customers through Urgent Medical Device Correction letters. Customers were provided with instructions for continued use of their MR systems. All potential users should be made aware of this safety notification and recommended actions. If you have any questions or concerns regarding this notification, please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026