GE Medical Systems China is recalling 1,638 units of the F2-01 Frame physiological patient monitor due to a potential software issue that causes data communication to fail. This defect occurs if the frame has not been powered down within the last 120 days, causing the E-modules to stop communicating with CARESCAPE ONE and CARESCAPE Canvas 1000 monitors. No specific injuries have been reported, but the failure to monitor patient data could lead to delayed medical treatment. Consumers should contact GE Medical Systems or their healthcare provider for technical assistance.
If the device remains powered on for more than 120 days, the internal communication between the patient monitoring modules and the display unit can fail. This prevents vital patient data and arrhythmia alarms from being displayed, potentially missing critical changes in a patient's condition.
Establish maintenance procedures for power cycles and contact the firm.
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
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