Xhibit Telemetry Receiver may shut down, causing temporary loss of patient monitoring
Spacelabs Healthcare's Xhibit Telemetry Receiver (Model 96280) may experience a Windows proxy issue causing the system to restart and go offline for 1-1.5 minutes, creating a temporary gap in patient monitoring.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: No hospitalizations or injuries have been reported. This meets the High severity criterion as a risk-of-harm medical device where the monitoring loss could delay clinical intervention if a patient event occurs during the offline period.
Plain-English summary
Spacelabs Healthcare is recalling the Xhibit Telemetry Receiver, Model 96280, due to a Windows proxy issue that can cause the system to shut down and restart unexpectedly. The device is intended to provide real-time patient monitoring in clinical settings. Approximately 2,265 units have been distributed across hospitals and healthcare facilities in the United States, Puerto Rico, and internationally including Canada, Mexico, the United Kingdom, and others.
When the Windows proxy issue occurs, the system restarts and displays as 'Offline' for approximately 1 to 1.5 minutes. During this period, patient monitoring is temporarily unavailable. If a patient experiences a clinical event during the downtime, clinical staff may not detect the event until monitoring resumes after the system restarts. This delay in detection could prevent timely clinical intervention.
Healthcare providers using this device should be aware of the potential for temporary monitoring loss and should implement appropriate safeguards to ensure continuous patient supervision during system restarts. Contact Spacelabs Healthcare for further guidance and possible remediation options.
The recalled product
- Product
- Xhibit Telemetry Receiver, Model 96280, with Service Manual. Intended to provide monitoring system with patient data.
- Manufacturer
- Spacelabs Healthcare, Inc.
- Affected units
- 2,265
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Service Manuals P/N 070-2409-07 and Prior. UDI-DI: 10841522107177
- 10841522100246
Distribution
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