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
- Distribution Dates: May 1, 2009 to December 22, 2021
- Devices Recalled in the U.S.: 56,671
- V60: 49,680
- V60 Plus: 6,991
- Date Initiated by Firm: March 10, 2022; updated April 28, 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 all V60 and V60 Plus ventilators because an internal power fluctuation may cause the ventilator to shut down unintentionally either with or without any visible or audible alarms. The power fluctuation causes a reboot of the backup alarm controller, which may lead to a complete shutdown of the ventilator without warning.
Affected ventilators may cease ventilation either with or without alarms. Such failures may lead to patients being deprived of oxygen for an extended time, which could cause serious adverse health consequences and death.
As of April 14, 2022, there have been reports of 4 injuries and 1 death associated with the use of the recalled devices.
Who May be Affected
- People who receive breathing support from Philips Respironics V60 or V60 Plus ventilators.
- Health care personnel who provide care for patients who receive breathing support from Philips Respironics V60 or V60 Plus ventilators.
What to Do
On March 14, 2022, Respironics California, LLC, issued an Urgent Medical Device Correction to all affected consignees. The firm advised customers to keep the affected Philips V60 and V60 Plus ventilators in service and use them in accordance with the instructions for use and the following guidance:
- Connect the Philips Respironics V60/V60 Plus to a nurse call/remote alarm system. The company strongly recommends using this strategy to provide a backup signal to the clinician if the ventilators primary alarm system does not activate. Directions to connect to a remote alarm are found in Section B-5 of the Operator’s Manual: Remote Alarm Port.
- Verify the operation of any nurse call/ remote alarm device before connected to the ventilator.
- Respond to all alarms. Immediate response to high-priority alarms from the ventilator and prompt response to low priority alarms are recommended.
- Install an oxygen analyzer/monitor. Follow the manufacturer’s instructions for setup, alarms, and calibration of this device.
- Provide pulse oximetry to inform the clinician of a change in the patient's condition.
- Ensure access to an alternative ventilation device. Always have immediate access to an alternative means of ventilation.
- If a Philips Respironics V60/V60 Plus ventilator experiences a shutdown,
- Disconnect the patient, and
- Immediately start ventilation with an alternate device.
The company also requested that customers acknowledge receipt of the recall notification by fax or email.
On April 22, 2022, Respironics California, LLC, issued an update to its Urgent Medical Device Correction to all affected consignees, advising its customers to conduct a risk/benefit analysis to evaluate whether the impacted devices should continue to be used, if mitigations mentioned previously are not available.
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.