Recall Z-1502-2016— Spacelabs Healthcare Inc

Name: FDA recall Z-1502-2016
Creator: U.S. Food and Drug Administration
Published: 2016-03-28

Class II · Terminated

Class II FDA medical device recall by Spacelabs Healthcare Inc, initiated 2016-03-28, terminated 2016-12-19. It names one FDA 510(k) clearance: K141156. Product: The Spacelabs Healthcare Xhibit Telemetry Receiver (XTR), Model 96280 is used to transmit patient(s) physiological measurements and data to a monitor.. Reason: 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..

Recalling firm: Spacelabs Healthcare Inc
Classification: Class II
Status: Terminated
Initiated: 2016-03-28
Terminated: 2016-12-19
Firm location: Snoqualmie, WA, United States

510(k) clearances named in this recall

1 on FDA's record

K141156 — SPACELABS HEALTHCARE TELEMETRY RECEIVERSpacelabs Healthcare·cleared 2014-09-09

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.