GE Medical Systems Information Technologies Inc — Class II: GE Healthcare MAC VU360, REF# part number 2030361-023; Electrocardiograph
GE Medical Systems Information Technologies Inc has initiated a Class II recall for the MAC VU360 v3.0 electrocardiograph due to a software defect where preview or review screens may fail to auto-close after two minutes of inactivity following an order refresh. This failure could cause patient data to persist on the display and be erroneously attributed to a subsequent patient.
This affects GE Medical Systems Information Technologies Inc and healthcare facilities utilizing the MAC VU360 v3.0 electrocardiograph (REF# 2030361-023), specifically clinical staff performing ECGs and hospital IT/Risk Management departments.
This issue presents a risk to data integrity and patient identification, as the persistence of stale patient data could lead to diagnostic errors or incorrect documentation. From a regulatory perspective, this suggests a failure in the software's state-management logic during specific user interactions (order refreshing), highlighting potential gaps in automated timeout validation during the software development lifecycle.
Biomedical and IT departments should verify software versions on MAC VU360 units and ensure clinicians are trained to manually close screens between patients. QA teams should evaluate if existing software validation protocols for auto-timeout features are sufficient to detect screen persistence issues under specific workflow triggers like order refreshing.
Class II. Reason: Software issue issue with the MAC VU360 v3.0 system. After selecting the order refresh icon, an open preview or review screen might fail to close automatically after 2 minutes of inactivity. As a result, data from a previous patient may remain on the screen and could be incorrectly associated with a subsequent patient.. Product: GE Healthcare MAC VU360, REF# part number 2030361-023; Electrocardiograph. Firm: GE Medical Systems Information Technologies Inc (Milwaukee WI United States). Status: Ongoing.
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