Company: Spacelabs Helathcare Inc.
Date of Enforcement Report 10/5/2016
Class lI:
PRODUCT
Spacelabs Healthcare Xhibit Central Station, Model 96102. Xhibit Telemetry Receivers (XTR) must be connected to an Xhibit Central Station for the display of patient vital signs.
Recall Number Z-2885-2016
REASON
The firm received multiple reports of Xhibit Telemetry System going offline or locking up. In addition, short-duration asystole alarms may not display an audio and visual alarm as reported from a single Canadian hospital.
RECALLING FIRM/MANUFACTURER
Spacelabs Healthcare Inc., Snoqualmie, WA on 9/26/2016. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
798 units total (488 units in the US and 310 units outside US)
DISTRIBUTION
Nationwide and Internationally
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