ImtMedical, a subsidiary of Vyaire Medical, has initiated a recall of certain Bellavista ventilators, due to a software and configuration issue. The BellaVista 1000e ventilator netted U.S. FDA clearance in late 2019.
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 clinical use and require rebooting to restore ventilation.
Read the full article on Mass Device.