Philips Ventilator Recall: What You Need to Know

Philips Respironics has recalled more than 16,000 ventilators in the United States due to a problem with the machines' oxygen flow. The recall affects 2 ventilator models sold between May 1, 2009, and June 2, 2021:¹

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

The U.S. Food and Drug Administration (FDA) has defined the recall as a “Class I,” which is the most serious recall level. This means using the product could result in serious injury or death.¹

It is important to note that this is a separate recall from one announced in June 2021. The previous recall also involved mechanical ventilator devices and included BiPAP and CPAP machines.

Why did Philips recall these products?

Some people who use the recalled ventilators depend on them for a higher than normal flow of oxygen. When the device reaches the highest pressure level, it limits the amount of oxygen. A doctor must fix the issue or the person using the machine will continue to receive a lower oxygen flow rate.¹

The ventilator will also send out a “low-priority” alarm even though it may be a high-priority problem. This malfunction could lead to critical problems, including death.¹

As of August 2021, the FDA has reported 61 incidents linked to the ventilators. This includes 25 injuries but no reports of deaths.¹

How can I find out if my device is affected?

If you have purchased a V60 or V60 plus ventilator, you should receive a letter from Philips Respironics about the recall. The letter will contain log-in information for the Philips registration website. After registering your device online, Philips will notify you with more information about the recall as it becomes available.²

Contact Philips Respironics at 877-907-7508 with questions or if you are unsure whether the recall affects your device.²

What steps should I take now?

If you are a caregiver for someone who uses a recalled ventilator, keep a close eye on their oxygen levels. Respond to all alarms right away, even if it is a “low-priority” alarm. Avoid high-flow therapy if you cannot constantly monitor the person using the ventilator.^1,2

Philips Respironics has inserted an update to its V60 user manual in the recall letter to consumers. The company has also posted an educational video to its website. Review these materials for more information about the affected products.^1,2

If you notice a problem with your ventilator, you can also contact MedWatch, the FDA’s medical product safety program.³