According to an FDA alert, Vyaire Medical issued a bellavista ventilator recall for its 1000 and 1000e Series Ventilators after reports of ventilators failing to ventilate and generating a technical failure alarm, with specific software versions and configure combinations.
Previously, the FDA reported a “voluntary field correction” issued by Vyaire and imt medical ag for certain versions of the ventilators. The latest FDA alert now classifies this as a Class I recall “due to software configurations” and inclusive of all bellavista 1000 and 1000e ventilators.
The recall affects an estimated 2,605 devices distributed from January 26, 2017 to December 23, 2021.
According to the FDA, issues with the software version 6.0.1600.0 or higher installed can have a conflict in memory between software tasks when the data communication port is set to “HL7,” which produces the technical failure alarm 305. The use of affected ventilators may cause the ventilator to malfunction or stop, which may cause serious adverse events.
There have been 18 complaints, seven injuries, and no reports of death, the FDA reports.
More information is available on the FDA website.
bellavista ventilator recall
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