GE Healthcare (China) Co., Ltd. is recalling 3,022 units of various Magnetic Resonance (MR) Imaging systems, including SIGNA Creator, SIGNA Explorer, Brivo MR355, Optima MR360, and several SIGNA MR models. These systems contain a software defect that may allow an operator to incorrectly resume a scan after a power safety trip, even when safety limits are exceeded. This recall was initiated voluntarily by the firm to address a potential defect that could result in excessive tissue heating for patients.
The software error may allow a scan to proceed earlier than intended after a safety interruption. This can lead to excessive tissue heating or burns, especially if the patient has a medical implant or is in contact with conductive materials. No incidents or injuries have been reported to date.
Recall #: Z-1239-2025 | Quantity: 2538 units.
Recall #: Z-1240-2025 | Quantity: 22 units.
Recall #: Z-1241-2025 | Quantity: 33 units.
Recall #: Z-1242-2025 | Quantity: 241 units.
Recall #: Z-1243-2025 | Non-US Only | Quantity: 188 units.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.