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Spacelabs Healthcare Inc recalls Spacelabs Healthcare Xhibit Telemetry Receiver (XTR), Model 96280. Xhibit Telemetry Receivers (XTR) must be connected t
Recalled October 5, 2016 · FDA recall Z-2886-2016 · Spacelabs Healthcare
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. · FDA Class II
Units
316 XTR units total (248 units in the US and 68 units outside US)
Sold at
Worldwide distribution. US nationwide including Puerto Rico, Australia, Canada, China, France, Germany, Ireland, Italy, Netherlands, Philippines, Poland, Romania, Switzerland, and United Kingdom.
Description
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.
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.
Manufacturer(s)
Spacelabs Healthcare Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →