Recall Z-2885-2016— Spacelabs Healthcare Inc

Name: FDA recall Z-2885-2016
Creator: U.S. Food and Drug Administration
Published: 2016-08-25

Class II · Terminated

Class II FDA medical device recall by Spacelabs Healthcare Inc, initiated 2016-08-25, terminated 2017-03-13. It names one FDA 510(k) clearance: K122146. Product: Spacelabs Healthcare Xhibit Central Station, Model 96102, Version 1.1.2. Xhibit Telemetry Receivers (XTR) must be connected to an Xhibit Central Station for the display of patient vital signs.. Reason: 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..

Recalling firm: Spacelabs Healthcare Inc
Classification: Class II
Status: Terminated
Initiated: 2016-08-25
Terminated: 2017-03-13
Firm location: Snoqualmie, WA, United States

510(k) clearances named in this recall

1 on FDA's record

K122146 — XHIBIT CENTRAL STATION, MODEL 96102Spacelabs Healthcare·cleared 2013-04-22

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

Spacelabs Healthcare Xhibit Central Station, Model 96102, Version 1.1.2. 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.

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