FDA-Device2022-04-20Class II

Breas Ventilator Trolley with the Vivo 50/60/65 and Vivo 45LS ventilator models Article no 007384

Breas Medical, Inc.
Hazard

Ventilator mounting brackets for the Vivo 50/60/65 and Vivo 45LS ventilator models can become detached from the Breas Ventilator Trolley, this may cause the ventilator to fall from the trolley and cause injury to a person who is in the immediate proximity

Sold states
US Nationwide
Affected count
707 units
Manufactured in
16 Esquire Rd, N/A, North Billerica, MA, United States
Products
Breas Ventilator Trolley with the Vivo 50/60/65 and Vivo 45LS ventilator models Article no 007384

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0943-2022

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