Spacelabs Healthcare Inc recalls The Spacelabs Healthcare Xhibit Telemetry Receiver (XTR), Model 96280 is used to transmit patient(s) physiological meas…

Recall date

March 28, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1502-2016

FDA classification

Class II

Brand / firm

Spacelabs Healthcare Inc

Sold / distributed

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.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

The Spacelabs Healthcare Xhibit Telemetry Receiver (XTR), Model 96280 is used to transmit patient(s) physiological measurements and data to a monitor.