Reported Aug 17, 2022 · Ongoing
Xhibit Telemetry Receiver, Model: 96280
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
- Model96280
- Lot codes and dates
- UDI-DI
10841522100246Software version 1.4.0
- Serial Numbers
529 of 529 codes
6280-0015386280-0005906280-0005896280-0003399280-0007116280-0011036280-0011026280-0014696280-0014676280-0016866280-0013996280-0013236280-0004576280-0004566280-0004556280-0004406280-0004396280-0004386280-0004296280-0004766280-0004756280-0016936280-0007036280-0007026280-0007016280-0007006280-0003146280-0002586280-0001576280-0012236280-0012226280-0012216280-0012206280-0012196280-0012186280-0012176280-0012166280-0012156280-0012146280-0012076280-0011276280-0011256280-0011246280-0011236280-0010566280-0010556280-0010546280-0010536280-0010526280-0010516280-0010506280-0012886280-0012876280-0014906280-0016926280-0005886280-0005176280-0005166280-0005156280-001668
- UDI-DI
- Amount recalled
- 529
Where it was sold
Why it was recalled
Software related alarm escalation defect occurs after approximately 25 days of continuous use. Technical alarm escalation for the following alarms, signal loss, all leads off, low battery, SpO2 sensor off, and signal interference, does not occur in the telemetry receiver as specified. Caregiver may not respond to the initial technical alarm and may not be aware of the continuing technical failure.
This product could cause temporary or reversible health problems — stop using it.
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