FDA-Device2016-10-05Class II
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.
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
316 XTR units total (248 units in the US and 68 units outside US)
Manufactured in
35301 SE Center St, N/A, Snoqualmie, WA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2886-2016Don't want to check this manually?
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