FDA-Device2016-10-05Class II
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.
Spacelabs Healthcare Inc
Hazard
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.
Sold states
Worldwide distribution. US nationwide including Puerto Rico, Australia, Canada, China, France, Germany, Ireland, Italy, Netherlands, Philippines, Poland, Romania, Switzerland, and United Kingdom.
Affected count
798 units total (488 units in the US and 310 units outside US)
Manufactured in
35301 SE Center St, N/A, Snoqualmie, WA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2885-2016Don't want to check this manually?
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