FDA-Device2016-04-27Class II
The Spacelabs Healthcare Xhibit Telemetry Receiver (XTR), Model 96280 is used to transmit patient(s) physiological measurements and data to a monitor.
Spacelabs Healthcare Inc
Hazard
Reports of an abnormally high frequency of squelch events on Xhibit Telemetry Receivers (XTR), which is indicative of the loss of the telemetry data signal. In some cases, the Xhibit Central Monitor was also reported to display an Xhibit Offline error message for all patients being monitored.
Sold states
distributed in AL, AZ, CA, CO, CT, FL, ID, IN, KY, MI, MN, MO, MS, MT, SC, TX, WY and in the following countries: AUSTRALIA, CANADA, CHINA, FRANCE, NETHERLANDS, PHILIPPINES, ROMANIA, and UNITED KINGDOM.
Affected count
217 units of XTRs and 531 units of PCBAs (164 XTRs and 425 PCBAs in US and 53 XTRs and 106 PCBAs outside the US)
Manufactured in
35301 SE Center St, N/A, Snoqualmie, WA, United States
Products
The Spacelabs Healthcare Xhibit Telemetry Receiver (XTR), Model 96280 is used to transmit patient(s) physiological measurements and data to a monitor.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1502-2016Don't want to check this manually?
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