Reported Jul 20, 2022 · Ongoing
Vivo 45LS Ventilator- intended to provide continuous or intermittent ventilatory support for the care of individuals…
Breas Medical, 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: Breas Medical, Inc. · 16 Esquire Rd · North Billerica, MA · 01862-2527
Is this the product you have?
- Vivo 45LS Ventilator- intended to provide continuous or intermittent ventilatory support for the care of individuals who require
- mechanical ventilation Model Number230000 ¿ If the recalled product is a software
- include version numberfirmware versions 5.0.5 or earlier
- Lot codes and dates
- Unique Device Identifier (UDI)UDI 07321822300004
- Serial number ranges in scope areD******, K******, M01**** to M040124, where asterisk (*) denotes a digit from 0 to 9
- Amount recalled
- 1,113 units
Where it was sold
- Nationwide
Why it was recalled
A forced shutdown of one of the processors did not generate a watch dog alarm, would develop into a failure AND the instructions to monitor a ventilator dependent patient are NOT followed, the health consequences could potentially be Permanent impairment or life threatening if medical intervention is not obtained
This product could cause temporary or reversible health problems — stop using it.
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