FDA Medical Device Recalls (openFDA)
GE Healthcare (China) Co., Ltd.: Optima MR360, NMRI system
- Recall number
- Z-1241-2025
- Recalling firm
- GE Healthcare (China) Co., Ltd.
- Product
- Optima MR360, NMRI system
- Status
- Open, Classified
- Initiated
- 2025-01-31
- Posted
- 2025-02-28
- Terminated
- not on file
- 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.
- Root cause
- Software design
- Action
- 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.
- Quantity
- 33
- Distribution
- Domestic US distribution nationwide. International distribution worldwide.
- Lot, serial or model codes
- 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 (Update 12/29/25 - Additional System IDs 83027809699615, LV4026MR01) (Update 1/28/26 - Additional System ID 82427190104)
- 510(k) numbers
- ["K123417"]
- PMA numbers
- not on file
- Product code
- LNH
- Firm FEI
- 3008284470
- Firm city
- Beijing
- Firm state
- not on file
- Firm country
- China
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28