Recall Z-1242-2025— GE Healthcare (China) Co., Ltd.

Name: FDA recall Z-1242-2025
Creator: U.S. Food and Drug Administration
Published: 2025-01-31

Class II · Ongoing

Class II FDA medical device recall by GE Healthcare (China) Co., Ltd., initiated 2025-01-31. It names one FDA 510(k) clearance: K143251. 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..

Recalling firm: GE Healthcare (China) Co., Ltd.
Classification: Class II
Status: Ongoing
Initiated: 2025-01-31
Firm location: Beijing, N/A, China

510(k) clearances named in this recall

1 on FDA's record

K143251 — SIGNA Creator, SIGNA ExplorerGe Healthcare (Ge Medical Systems, LLC)·cleared 2015-02-04

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

SIGNA MR355, SIGNA MR360, NMRI system

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.