Reported May 10, 2023 · Ongoing
Ultraview SL (UVSL) Command Module, Model 91496
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?
- Ultraview SL (UVSL) Command Module, Model 91496
- Lot codes and dates
- Software version 2.03.06 and earlier and software version 2.04 and later.
- Amount recalled
- 1,088
Where it was sold
Why it was recalled
Command modules will display the following when parameter processing is suspended, depending on software version: 1) Older versions will have waveforms present with no alarms, 2) Newer versions have waveforms absent with no alarms. This may cause clinicians to miss a potentially catastrophic event.
This product could cause temporary or reversible health problems — stop using it.
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