Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2885-2016 — Spacelabs Healthcare Xhibit Central Station, Model 96102, Version 1.1.2. Xhibit Telemetry Receivers (XTR) must be connected to an Xhibit Central Station for the display of patient vital signs.

U.S. FDA — Device Enforcement · United States · 2016-08-25 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2885-2016
Date of alert
2016-08-25
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Spacelabs Healthcare Inc
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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