Company: Spacelabs Healthcare, Llc
Date of Enforcement Report: 11/27/2013
Class lI:
PRODUCT
Spacelabs Healthcare qube Compact Patient Monitor, Model 91390. It is a patient monitor with arrhythmia detection or alarms. The qube is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a hospital environment. These devices determine a) when an alarm condition is violated; b) the alarm priority (i.e. high, medium or low); c) alarm limits; and d) when to initiate and terminate alarm notifications. Recall Number Z-0351-2014
REASON
Spacelabs Healthcare qube Compact Patient Monitor, Model 91390, may fail to power ON due to incorrect programmed microcontroller component..
RECALLING FIRM/MANUFACTURER
Spacelabs Healthcare, Llc, Snoqualmie,WA on 10/17/2013. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
54 units total (42 units in the US and 12 outside US)
DISTRIBUTION
Nationwide and Internationally
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