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.
Please be aware, this recall is a voluntary correction, not a product removal.
- Product Names: Philips Respironics V60 Ventilators and V60 Plus Ventilators
- Product Codes: See Recall Database Entry
- Distribution Dates: May 6, 2023 to May 6, 2023
- Devices Recalled in the U.S.: 8
- Date Initiated by Firm: August 25, 2023
Philips Respironics V60 Ventilators and V60 Plus Ventilators are used to provide breathing assistance to pediatric and adult patients. A ventilator is intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen. V60 Ventilators and V60 Plus Ventilators are intended to be used inside hospitals.
Reason for Recall
Philips Respironics, Inc. is recalling their V60 Ventilators and V60 Plus Ventilators. The ventilators contain Power Management Printed Circuit Board Assemblies (Power Management PCBA) that were distributed by a third-party warehouse. The Power Management PCBAs do not meet ventilators standards.
The V60 Ventilators and V60 Plus Ventilators are not always used in Intensive Care Units (ICUs) where patients are directly monitored. There may be greater risk for patients who are not directly monitored in other hospital settings.
The use of the affected ventilators may cause serious adverse health consequences, including power failure, loss of ventilator function, and death.
There have been no reports of death or injuries related to this recall.
Who May be Affected
- People who receive breathing support from the affected Philips Respironics V60 Ventilators and V60 Plus Ventilators.
- Health care providers who provide care for patients who receive breathing support from the affected Philips Respironics V60 Ventilators and V60 Plus Ventilators.
What to Do
On August 25, 2023, Philips Respironics sent all affected customers an Urgent Medical Device Correction letter.
The letter requested customers to discontinue use of the devices and quarantine them. A Philips Respironics representative will contact the customers. The representative will provide instructions to remove or replace the Power Management PCBAs in the affected devices.
If you need any further information or support with this issue, please contact your local Philips Respironics representative, or call the Philips Respironics Customer Care Solutions Center at 1 (800) 722-9377.
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.