XTR 96280Recalls & reported problems

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

2 FDA recall records name this device's identifier, 2 still open.

4 other recalls cover devices cleared under the same FDA submission (K141156); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Nov 25, 2024Open, Classified

   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.

   Z-0809-2025 · Root cause: Labeling design · FDA record ↗

2. Nov 25, 2024Open, Classified

   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.

   Z-0810-2025 · Root cause: Software change control · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K141156. One submission often covers many models, so check the product and lot details in each record.

• Z-1513-2022 · May 31, 2022 · Open, Classified
  Xhibit Telemetry Receiver, Model: 96280
• Z-0532-2018 · Jan 17, 2018 · Terminated
  Spacelabs Healthcare Xhibit Telemetry Receiver, Model 96280, software version 1.1, physiological patient monitor (with arrhythmia detection or alarms) The Spacelabs Healthcare Tel
• Z-2886-2016 · Aug 25, 2016 · Terminated
  Spacelabs Healthcare Xhibit Telemetry Receiver (XTR), Model 96280. Xhibit Telemetry Receivers (XTR) must be connected to an Xhibit Central Station for the display of patient vital
• Z-1502-2016 · Mar 28, 2016 · Terminated
  The Spacelabs Healthcare Xhibit Telemetry Receiver (XTR), Model 96280 is used to transmit patient(s) physiological measurements and data to a monitor.