The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
- Product Name: Philips Respironics V60 and V60 Plus Ventilator
- Product Codes and Serial Numbers: See recall database entries:
- Distribution Dates: July 29, 2021 to August 11, 2021
- Devices Recalled in the U.S.: 1,511
- Date Initiated by Firm: January 24, 2022
The Philips Respironics V60 and V60 Plus ventilators are intended to support patient breathing. They are used to provide mechanical ventilation for adults and children who can breathe on their own, for example those with respiratory failure, chronic respiratory insufficiency, or obstructive sleep apnea. The ventilators are used in hospitals or other institutional settings under the direction of health care professionals.
Reason for Recall
Philips Respironics is recalling Certain V60 and V60 Plus ventilators because a subset of these devices had parts that were put together using an expired adhesive. If the adhesive fails, it 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. This failure may cause an alarm to notify the health care provider, or it may not sound any alarm at all.
If ventilation stops and sounds an alarm, patients could be without ventilation support for the duration required for an alternate ventilator to be connected. 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.
There have been no reports of injuries, adverse health consequences, or death associated with the use of these devices.
Who May be Affected
- People receiving care with the Philips Respironics V60 or V60 Plus ventilators.
- Health care personnel who provide care for patients using Philips Respironics V60 or V60 Plus ventilators.
What to Do
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.”
Customers with questions or concerns about this recall should contact Philips Respironics 24/7 - Customer Care Solutions Center at 1-800-722-9377.
- Medical Device Recall Database Entries
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.