Philips Respironics is recalling certain V60 and V60 Plus ventilators due to an expired adhesive in what the FDA has labeled a Class I recall, according to an agency announcement.
An FDA alert reports a subset of V60 and V60 Plus devices had parts that were put together using an expired adhesive, which, if it fails, “could cause a capacitor support bracket to become loose and potentially damage the capacitors, which could cause the ventilator to stop providing ventilation to the patient.” The FDA said the failure may or may not sound an alarm.
“If ventilation stops and sounds an alarm, patients could be without ventilation support for the duration required for an alternate ventilator to be connected,” the FDA alert stated. “If the ventilator does not sound an alarm when the ventilation stops, the patient could be deprived of oxygen for an extended time, which could cause serious adverse health consequences and death.”
The agency said there have been no reports of injuries, adverse health consequences, or death associated with the use of V60 and V60 Plus ventilators.
A total of 1,511 ventilators have been recalled in the US, the FDA reported. The affected Philips Respironics V60 and V60 Plus Ventilators were distributed between July 29, 2021 to August 11, 2021 and have the following product codes and serial numbers:
Philips V60 Recall: FDA Recommendations
On January 24, 2022, Philips Respironics sent an Urgent Medical Device Correction Notice to distributors and customers with the following instructions:
- Compare device serial numbers to the provided list of impacted serial numbers to determine if a ventilator is impacted. Device serial number information can be located at the rear of the ventilator. Alternatively, the serial number of the ventilator may be viewed from the display while the ventilator is in operation by selecting the Menu tab at the bottom of the screen then “Vent Info.”
- Connect the ventilator to a remote alarm system, if available, as described in Section B-5: “Remote Alarm Port” of the Operator’s Manual. The remote alarm will provide a backup warning even if the ventilator’s primary alarm system does not alarm. It is not necessary to remove affected Philips V60/V60 Plus ventilators from service.
- Follow directions in the Operator’s Manual and the Urgent Medical Device Correction Letter to further reduce any risk associated with this potential failure.
- Provide external oxygen monitoring to minimize patient risk in case of O2 supply loss or ventilator failure.
- Promptly respond to all low priority alarms and immediately respond to all high-priority alarms presented by the ventilator.
- Always have immediate access to an alternative means of ventilation.
- If a Philips V60/V60 Plus ventilator experiences a shutdown:
- Disconnect the patient and immediately start ventilation with an alternate device.
- Contact a local customer service contact to report the failure and to schedule corrective maintenance.
- Acknowledge receipt of Philips Respironics Urgent Medical Device Correction Notice by fax or e-mail as noted on the “Urgent Medical Device Correction Response Form.”
More information is available on the FDA website.