Royal Philips (NYSE:PHG) Respironics business is recalling a select number of its V60 respiratory ventilators with its 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 affects 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.
Philips cautioned that the v2.20 software “may falsely detect that the blower motor has stalled” which could cause the software to shut the ventilator down and display error code 100E.
The error will be announced by a high-priority alarm for at least 2 minutes when the unit shuts down, the company said.
Should a ventilator stop due to the error, patients could face adverse events, including hypoxemia or hypercarbia due to a lack of oxygen.
Philips instructed customers to examine their devices to determine if they have the v2.20 software and to discontinue use of the devices until an appropriately functional software is installed, according to an urgent field safety notice.