On June 18th, 2021, Philips issued an “Urgent Field Safety Notice” informing V60 and V60 Plus ventilators users that these devices may not be providing the user with enough oxygen. Then, on June 30, 2021, Philips issued an official recall of its V60 and V60 Plus ventilators over this exact issue. The June 30 recall is unrelated to Philip’s recall on June 14, 2021 of certain CPAPs, BiPAPs and other ventilators the company makes. The FDA has classified the most recent recall of Philips’ V60 and V60 Plus ventilators as the “most serious type of recall.”
The devices in question are Philips Respironics V60 (upgraded to versions 3.00 and 3.10 to enable for High-Flow Therapy) and V60 Plus ventilators distributed between May 1st, 2009 and June 2nd, 2021. In a statement provided by the FDA, 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 blocked (even partially) for any reason. According to the FDA, if the issue is not corrected immediately, the device will continue to provide the user with a “lower oxygen flow rate and issue a low priority alarm”, which “may cause serious injuries or even death.”
So far, there have been over 16,000 devices recalled in the US with reports showing at least 85 injuries or other incidents related to their use. At this time, no deaths have been reported.
Since the June 30 recall, the FDA advised the following instructions for users of V60 and V60 Plus ventilators:
- 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.
- 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.
The full list of the FDA instructions and other important information regarding this recall can be found in their official statement.
Boesen Law Firm prides itself on helping its clients review and pursue the best legal path forward with our 36 years of in-field expertise. Our experienced Philips Respironics lawyers at Boesen Law Firm can help individuals who are facing issues caused by Philips devices.