Recall Z-0810-2025— Spacelabs Healthcare, Inc.

Name: FDA recall Z-0810-2025
Creator: U.S. Food and Drug Administration
Published: 2024-11-25

Class II · Ongoing

Class II FDA medical device recall by Spacelabs Healthcare, Inc., initiated 2024-11-25. It names one FDA 510(k) clearance: K141156. Product: Xhibit Telemetry Receiver with Software, Model 96280. Intended to provide monitoring system with patient data.. Reason: Telemetry receivers with affected software versions may experience unsolicited system shut down and restart (Offline displayed), lasting approximately 1 to 1.5 minutes, which will cause temporary loss of monitoring. If a clinical event occurred during this period, staff may not detect until the system restarts and necessary clinical intervention could be delayed..

Recalling firm: Spacelabs Healthcare, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2024-11-25
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 with Software, Model 96280. Intended to provide monitoring system with patient data.

Reason for recall

Telemetry receivers with affected software versions may experience unsolicited system shut down and restart (Offline displayed), lasting approximately 1 to 1.5 minutes, which will cause temporary loss of monitoring. If a clinical event occurred during this period, staff may not detect until the system restarts and necessary clinical intervention could be delayed.

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