The U.S. Food and Drug Administration (FDA) announced on June 3, 2022, that Philips Respironics would recall all V60 and V60 Plus ventilators. The FDA identified the Philips Respironics recall as a Class I recall, the most serious type of recall, for the potential to cause serious injuries or death.
The products recalled as part of the Philips Respironics recall are the Philips Respironics V60 and V60 Plus Ventilators, most of them distributed between May 1, 2009, to December 22, 2021. Intended to support patient breathing in clinical settings by providing mechanical ventilation and high flow oxygen therapy, the devices were used by patients who could still breathe on their own. That applied to conditions including respiratory failure, chronic respiratory insufficiency, and obstructive sleep apnea. According to the FDA, 56,671 of these devices are subject to recall in the United States.
Philips must recall the device because internal power fluctuation could cause the ventilator to shut down, possibly without any alarm or warning. Ventilator shut down could lead to extended oxygen and potentially death. The FDA indicates that an expired adhesive was one problem with affected ventilators.
Respironics California, LLC, initially issued an Urgent Medical Device Correction on March 14, 2022. At that time, they advised customers to keep the affected devices and follow guidance about connecting the devices to alarm systems. According to the FDA, 4 injuries and 1 death had been reported as of April 2022, requiring the change to Class 1 Recall.
This Philips Respironics recall follows a series of Philips respiratory device recalls, now including approximately 5.2 million devices. Breakdown of polyester-based polyurethane (PE-PUR) foam in some of Philips’ CPAP, BiPAP and Mechanical Ventilator devices in June 2021 prompted a recall. As described by the FDA, the breakdown meant that black pieces of foam, or certain chemicals, could be inhaled or swallowed by the person using the device, potentially resulting in serious injury. From April 2021 through April 30, 2022, the FDA reports receiving more than 21,000 medical device reports (MDRs), including 124 reports of death, associated with the PE-PUR foam breakdown.
New York | Brooklyn | Queens | Long Island | New Jersey | Florida
Call us at: 1-800-YOURLAWYER (800-968-7529) | Schedule your free consultation