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Breas Medical, Inc. recalls Vivo 45LS Ventilator- intended to provide continuous or intermittent ventilatory support for the care of individuals who
Recalled July 20, 2022 · FDA recall Z-1382-2022 · Breas Medical
Hazard
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 · FDA Class II
Units
1,113 units
Sold at
Nationwide
Description
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
Product
Vivo 45LS Ventilator- intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation Model Number: 230000 ¿ If the recalled product is a software, include version number: firmware versions 5.0.5 or earlier
Manufacturer(s)
Breas Medical, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →