Medical Device Recall: CARESCAPE Canvas Smart Display, Model Numbers: a) 5700023, b) 5700023-02, c) 5939590-102; monitor, physiological, patient
GE Healthcare Finland Oy · April 5, 2024
Reason for Recall
GE HealthCare has become aware of the potential for loss of monitoring on CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, and certain versions of CARESCAPE B850 and CARESCAPE B650 monitors if, following the replacement of the CPU timekeeper battery, a mains power loss occurs during active monitoring. In the unlikely event that this occurs, it can result in the displays or monitors not turning on, after the mains power is restored. This can result in a delay in recognizing changes in patient condition until a replacement monitor is connected.
Distribution
Worldwide distribution.
Quantity Affected
4649 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-2169-2024
Status: ongoing
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