Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0809-2025 — Xhibit Telemetry Receiver, Model 96280, with Service Manual. Intended to provide monitoring system with patient data.

U.S. FDA — Device Enforcement · United States · 2024-11-25 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0809-2025
Date of alert
2024-11-25
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Spacelabs Healthcare, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
10841522107177
Reported risk: Telemetry receiver systems may experience a Windows proxy Issue causing the system to 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; necessary clinical intervention could be delayed.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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