Reported Jan 15, 2025 · Ongoing
Xhibit Telemetry Receiver with Software, Model 96280. Intended to provide monitoring system with patient data.
Spacelabs Healthcare, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Spacelabs Healthcare, Inc. · 35301 Se Center St · Snoqualmie, WA · 98065-9216
Is this the product you have?
- Xhibit Telemetry Receiver with Software, Model 96280. Intended to provide monitoring system with patient data.
- Lot codes and dates
- Software Versions1.4.0 and 1.4.1
- UDI-DI
1084152210717710841522100246
- Amount recalled
- 434
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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