FDA-Device2022-07-20Class II
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
Breas Medical, Inc.
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
Sold states
Nationwide
Affected count
1,113 units
Manufactured in
16 Esquire Rd, North Billerica, MA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1382-2022Don't want to check this manually?
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