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.
Reported: October 5, 2016 Initiated: August 25, 2016 #Z-2886-2016
Product Description
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.
Reason for Recall
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.
Details
- Recalling Firm
- Spacelabs Healthcare Inc
- Units Affected
- 316 XTR units total (248 units in the US and 68 units outside US)
- Distribution
- Worldwide distribution. US nationwide including Puerto Rico, Australia, Canada, China, France, Germany, Ireland, Italy, Netherlands, Philippines, Poland, Romania, Switzerland, and United Kingdom.
- Location
- Snoqualmie, WA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Spacelabs Healthcare Inc. Units affected: 316 XTR units total (248 units in the US and 68 units outside US).
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 5, 2016. Severity: Moderate. Recall number: Z-2886-2016.
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