Philips Recall of Select V60 Ventilators Classified by FDA As 'Most Serious Type of Recall'

Philips Respironics, the U.S.-based health care company owned by Dutch technology firm Philips, has recalled a selection of its V60 ventilator devices due to a risk of "receiving reduced oxygen."

The U.S. Food and Drug Administration has identified the latest recall as a "Class I" recall, which was noted as "the most serious type of recall," according to an FDA statement Tuesday.

Using these devices "may cause serious injuries or death," the FDA warned.

The devices recalled include V60 Plus ventilators and all V60 ventilators upgraded to enable high-flow therapy (software version 3.00 and 3.10).

Some 16,535 of these devices were recalled in the U.S. No deaths were reported for this issue but there have been 61 incidents and 25 injuries, the FDA said.

The latest announcement follows a recall of select breathing devices issued by the company on June 30 "due to potential health risks," an FDA statement said at the time.

The FDA stated Tuesday that the latest recall is "separate and unrelated to the June 2021 Philips Respironics ventilator, BiPAP, and CPAP machine recall."

Why Were These V60 Ventilators Recalled?

The FDA statement explained the devices were recalled "due to the risk to the patients who rely on the ventilator to provide high flow oxygen therapy if the system pressure reaches the default maximum limit.

"This can occur if the oxygen flow is partially blocked for any reason. If the issue causing maximum system pressure is not resolved by the health care provider, the ventilator will continue to provide the patient with lower oxygen flow rate and issue a low priority alarm. This could lead to serious adverse events, including death."

Latest Philips Respironics Ventilators on Recall

Devices

• V60 Plus ventilators
• All V60 ventilators upgraded to enable High Flow Therapy (software version 3.00 and 3.10)

Distribution dates of devices: May 1, 2009 to June 2, 2021

Number of devices recalled in the U.S.: 16,535

Customers as well as health care professionals can report any adverse reactions or quality issues experienced while using these devices to "MedWatch: The FDA Safety Information and Adverse Event Reporting Program" using an online form or by mail or FAX. See the FDA website for more information.

What To Do When Using These Ventilators

On June 18, the company issued an "Urgent Field Safety Notice" to all affected customers, advising the following instructions when using this device for high flow oxygen therapy, as outlined in the latest FDA statement:

• Monitor the patient's oxygen saturation continuously.
• Provide constant and close monitoring of all patients who are dependent on supplemental oxygen and at risk of clinical deterioration to prevent dangerous drops in blood oxygen levels, work of breathing, respiratory distress and resulting escalation in medical treatment.
• Respond to all alarms urgently, regardless of alarm priority.
• Do not use high flow therapy if the patient cannot be constantly and closely monitored by the clinician.
• Refer to and follow the user manual addendum (attached to the safety notice) titled "V60 Plus User Manual Addendum: High-Flow Therapy Safety and Alarm Page 3 of 8 Features". This user manual addendum provides additional technical details about the "Cannot Reach Target Flow" (CRTF) alarm functionality.
• Watch the "Understanding HFT" video for additional information and education regarding this issue.
• Complete, sign, and return the "Acknowledgment and Receipt Form" sent with the letter.

See the FDA website for more information about the latest Philips Respironics recall.