Company: Spacelabs Helathcare Inc.
Date of Enforcement Report 10/5/2016
Class lI:

PRODUCT

Spacelabs Healthcare Xhibit Telemetry Receiver (XTR), Model 96280. Xhibit Telemetry Receivers (XTR) must be connected to an Xhibit Central Station for the display of patient vital signs.
Recall Number Z-2886-2016

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
316 XTR units total (248 units in the US and 68 units outside US)

DISTRIBUTION
Nationwide and Internationally

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