Class I recall designations, the agency’s most serious classification of recall, are used when there is a reasonable probability that product use could cause serious adverse health consequences or death.
The Respironics V60 non-invasive ventilator is designed to provide continuous or intermittent breathing support to pediatric patients weighing at least 44 lbs or adult patients, according to the recall notice.
The company is recalling the device over issues with pins within the internal cable that connects the ventilator’s motor to the control board which can become loose due to vibrations. A loose pin may prevent data from being transferred between the motor and control board, according to the FDA release, which could cause the ventilator to shut down unexpectedly and sound an alarm.
An unexpected stop in ventilation could cause serious adverse health consequences, including death, the FDA said.
The recall affects 20,690 V60 non-invasive ventilator units in the US manufactured between April 2, 2009 and Sept. 15, 2015 and distributed between April 4, 2009 and Sept. 14, 2015.
In March, Philips Respironics recalled a select number of its V60 respiratory ventilators with version 2.20 software over issues with the software causing the blower motor to stall and the unit to shut down, according to a recall notice released this week.
The recall affected all V60 ventilators manufactured between Aug. 17, 2016 and Jan. 4, 2017 with v2.20 software, the company said, with the caveat that the recall may affect units manufactured prior to Aug. 2016 which have had v2.20 software added in the field.