On January 10, the FDA announced on its website that it had notified healthcare professionals that Covidien’s Puritan Bennett 840 Series Ventilator has been recalled due to a software problem. The agency issued the Class 1 recall because a diagnostic code may be incorrectly triggered, setting off the safety alarm and requiring the patient to breathe without assistance.
The agency noted that Covidien had informed its customers of the problem via a voluntary field correction letter on December 16. The letter instructs users of the ventilator to install a software update to correct the problem, but that the ventilator may be used “until is it feasible to install” the update.
