Summary
The FDA issued a Class II for Optima MR360, NMRI system by GE Healthcare (China) Co., Ltd.. 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 .
Details
Source
Device Recall
External ID
Z-1241-2025
Action Date
2025-03-05
Status
Ongoing
Category
device
Product Description
Optima MR360, NMRI system
Lot/Code Info: 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)
Quantity Affected: 33
Reason for Recall
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.
Distribution
Domestic US distribution nationwide. International distribution worldwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-01-31
Company
Beijing, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 156 device recalls issued in the same week, part of 403 device-related FDA actions this month.
GE Healthcare (China) Co., Ltd. has 24 FDA actions in our database, including 24 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (GE Healthcare (China) Co., Ltd.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does GE Healthcare (China) Co., Ltd. have FDA actions?
GE Healthcare (China) Co., Ltd. has 24 FDA actions in our database, including 24 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1241-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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