Vyaire Medical recently announced that its subsidiary ImtMedical has initiated a voluntary field correction for certain BellaVista ventilators.
The company reported a potential issue with BellaVista 1000 and 1000e ventilators that have specific software and configuration combinations that can cease ventilation and generate a technical failure alarm. The issue affects ventilators distributed between Mar. 21, 2019 and Dec. 23, 2021, that have software version 6.0.1600.0 or higher installed, which was deployed in February 2021, and also have the data communication port set to “HL7.”
Vyaire Medical told customers with software version 6.0.1600.0 or higher installed to immediately disable the HL7 data communication if activated. The devices are at risk of unintentional ceasing of ventilation if the data communication is not disabled.
The recall was issued based on reports that some of the ventilators unintentionally ceased ventilation during clini…