First initiated on June 4, 2013, the manufacturer’s recall of approximately 19,200 Philips Respironics V60 ventilators has been given the Class I designation by FDA. That designation indicates that “there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.”

According to Respironics, the recall was initiated to correct an issue with power management printed circuit board assembly PIC software that was discovered through routine product monitoring. The problem could result in the loss of ventilator support, potentially with no audible alarm from the ventilator.

Respironics has corrected the software issue and will update the software on all V60 ventilators shipped from the manufacturer before April 1, 2013.