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GE Healthcare (China) Co., Ltd. Recall: Brivo MR355, NMRI system

GE Healthcare (China) Co., Ltd. Recall: Brivo MR355, NMRI system is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: GE Healthcare (China) Co., Ltd.; Product: Brivo MR355, NMRI system; Reason for recall: For certain MR systems, a scan can be resumed following a Power Monitor trip when the

Recalling firmGE Healthcare (China) Co., Ltd.
ProductBrivo MR355, NMRI system
Reason for recallFor 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.
ClassificationClass II (moderate — may cause temporary or reversible health consequences)
StatusOngoing
DistributionDomestic US distribution nationwide. International distribution worldwide.
Recall initiated20250131
Recall numberZ-1240-2025
Categorydevice
StateN/A
CountryChina

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