The U.S. Food and Drug Administration (FDA) issued notice that Philips Respironics recalled its V60 Plus Ventilators Equipped with High Flow Therapy (software version 3.00 and 3.10) and all V60 ventilators that have been upgraded to enable High Flow Therapy with this software. The manufacturer distributed the affected devices between May 1, 2009, and June 2, 2021. Within the U.S. alone, 16,535 devices have been recalled. More than 23,000 devices distributed worldwide have been recalled.
Philips initiated the recall on June 18, 2021. It is identified as a Class I recall, which is the most serious type of recall under the FDA’s classification criteria. This means that using the recalled devices could cause serious injuries or death.
The recall affects health care providers who administer treatment using the V60 and V60 Plus Ventilators, as well as the patients whose care requires these machines.
Why the Ventilators Were Recalled
The recalled Philips ventilators pose a risk to patients who depend on the devices’ ability to provide high flow oxygen therapy if that flow becomes partially blocked. This blockage causes the units to reach their default maximum limit, according to Philips’ Urgent Field Safety Notice, issued in June 2021. If unresolved, the device delivers patients’ oxygen at a flow rate lower than what the clinician prescribed, issuing a low-priority “Cannot Reach Target Flow” alarm. These patients will experience oxygen desaturation described as a “moderate or severe hypoxemia.”
According to the FDA, 61 such incidents have been reported, with 25 injuries and no deaths to date. However, the notice does state that the risk of the ventilator’s malfunctioning in this manner could lead to “serious adverse events, including death.”
Instructions for Customers Who Administer the Affected Philips Ventilators
The FDA informs customers of the V60 and V60 Plus Ventilators Equipped with High Flow Therapy to follow specific instructions when administering the devices to patients:
- Continuously monitor the amount of oxygen in the patient’s blood (SpO2)
- Keep constant and close monitoring of patients who are dependent on supplemental oxygen to prevent “dangerous drops in blood oxygen levels, work of breathing and respiratory distress and resulting escalation in medical treatment”
- Urgently respond to any and all alarms, even if they appear to be low priority
- Review the User Manual Addendum for the V60 Ventilator to learn more about the device’s alarm functionality and features.
- Watch Philips’ “Understanding HFT” video to learn more about the issue.
The FDA’s instructions further advise that health care providers not administer High Flow Therapy if they cannot monitor a patient constantly and closely.
For updates on the Class I recall, interested individuals may visit the FDA’s Medical Device Recall Database entry for the Philips V60 Plus Ventilator.