Reported Feb 14, 2018 · Terminated
Spacelabs Healthcare Xhibit Telemetry Receiver, Model 96280, software version 1.1, physiological patient monitor (with…
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?
- Spacelabs Healthcare Xhibit Telemetry Receiver, Model 96280, software version 1.1, physiological patient monitor (with arrhythmia detection or alarms) The Spacelabs Healthcare Telemetry Receiver, Model 96280, is intended to provide the Spacelabs Healthcare monitoring system with adult, pediatric and neonatal patient data of patients connected to Spacelabs Healthcare telemetry transmitters. Data includes physiological waveforms and calculations, cardiac arrhythmia and ST data, and patient demographic information to monitor adequacy of treatment or to exclude causes of symptoms.
- Lot codes and dates
- Serial numbers
6280-0003596280-0003406280-0003366280-0005036280-0005026280-0005006280-0004966280-0004956280-0003276280-0002606280-0005666280-000290
- Serial numbers
- Amount recalled
- 12 systems
Where it was sold
Why it was recalled
Spacelabs has received multiple complaints reporting telemetry beds dropping off the Spacelabs Central Station resulting in a loss of monitoring.
This product could cause temporary or reversible health problems — stop using it.
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