Recall Z-1513-2022— Spacelabs Healthcare, Inc.

Name: FDA recall Z-1513-2022
Creator: U.S. Food and Drug Administration
Published: 2022-05-31

Class II · Ongoing

Class II FDA medical device recall by Spacelabs Healthcare, Inc., initiated 2022-05-31. It names one FDA 510(k) clearance: K141156. Product: Xhibit Telemetry Receiver, Model: 96280. Reason: Software related alarm escalation defect occurs after approximately 25 days of continuous use. Technical alarm escalation for the following alarms, signal loss, all leads off, low battery, SpO2 sensor off, and signal interference, does not occur in the telemetry receiver as specified. Caregiver may not respond to the initial technical alarm and may not be aware of the continuing technical failure..

Recalling firm: Spacelabs Healthcare, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2022-05-31
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

Xhibit Telemetry Receiver, Model: 96280

Reason for recall

Software related alarm escalation defect occurs after approximately 25 days of continuous use. Technical alarm escalation for the following alarms, signal loss, all leads off, low battery, SpO2 sensor off, and signal interference, does not occur in the telemetry receiver as specified. Caregiver may not respond to the initial technical alarm and may not be aware of the continuing technical failure.

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