Software Issue Could Cause Sudden Shutdowns For Some Bellavista Ventilators
No patient injuries have been reported due to the problem, which is now the subject of a voluntary field correction.
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The US FDA on 17 February labeled a recall of 2,605 Bellavista 1000 and 1000e series ventilators as class I. Vyaire Medical Inc. had recalled the vents in late December.
The device giant is recalling Cobalt and Crome defibrillators because they may deliver weaker shocks than intended.
Agency won’t require manufacturers to submit class I devices to the database for an extra 75 days, and doesn't plan to enforce GUDID regulations against consumer health products.