About the Recall:
Breas Medical is issuing a voluntary field service correction on affected Breas Vivo 45 LS Ventilators equipped with firmware versions 5.0.5 or earlier
The affected devices include the Breas Vivo 45LS Ventilator distributed from January 28th, 2021, to March 29th, 2022.
Breas is recalling these products after discovering an exceptional condition during an internal bench test where a forced shutdown of one of the internal processers did not generate a watchdog alarm. Out of an abundance of caution, Breas has decided to correct this potential issue with a mandatory firmware upgrade even if there is no confirmed complaint or incident.
Customers who contact AdaptHealth subsidiaries with questions may be informed to contact Breas directly at 1-855-436-8724.
Impacted customers will receive written notification of the recall with instructions to report affected products and to arrange a visit from an AdaptHealth medical equipment technician to complete the firmware upgrade of the affected devices.
Additional questions can be directed to Breas via email at fsn@breas.com or online at www.breas.com.
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