GE Medical Systems Information Technologies Inc — Class II: Carescape Central Station CSCS V3 MAS800 Desktop Part Number 5867474-04, 5867474-13 P
GE Medical Systems Information Technologies Inc has initiated a Class II recall for Carescape Central Station CSCS V3 (MAS800 and MAI800) due to a defect where the device may not resume patient monitoring for at least three minutes following a system restart.
This recall affects GE Medical Systems Information Technologies Inc, clinical departments utilizing Carescape Central Stations, and biomedical engineering teams responsible for maintaining patient monitoring infrastructure.
A three-minute delay in patient monitoring resumption represents a significant gap in continuous surveillance, potentially leading to a failure to detect life-threatening events in a timely manner. This suggests a critical failure in the system's availability requirements and likely necessitates a software update or configuration change to ensure monitoring begins immediately upon system initialization.
Verify inventory for specific part numbers 5867474-04, 5867474-13, and 5867474-03. Ensure clinical staff are aware of the potential three-minute monitoring gap during system restarts and update institutional risk assessments to account for this delay in recognition of significant clinical events.
Class II. Reason: Device may not resume patient monitoring for at least 3 minutes following system restart. Issue can lead to potential delay in recognition of clinically significant events.. Product: Carescape Central Station CSCS V3 MAS800 Desktop Part Number 5867474-04, 5867474-13 Product code STU CSCS V3 MAI800 Integrated Part Number 5867474-03 Product Code STV. Firm: GE Medical Systems Information Technologies Inc (Waukesha WI United States). Status: Ongoing.
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