One Death, Four Injuries Linked to Recalled Philips Respironics Ventilators

The FDA issued an update on Philips Respironics’ March 10 recall of its V60 and V60 Plus ventilators, deeming it a Class 1 recall because of the risk of serious injury or death.

The agency said the devices were linked to one patient death and four injuries as of April 14.

The reason for the recall is that an internal power fluctuation may cause the ventilators to shut down either with or without a visible or audible alarm. The 56,671 affected products (49,680 V60s and 6,991 V60 Pluses) were distributed from May 1, 2009 to Dec. 22, 2021.

The V60 and V60 Plus ventilators, which are for use in hospitals or other institutional settings, provide mechanical ventilation for adults and children who can’t breathe on their own, for example those with respiratory failure, chronic respiratory insufficiency or obstructive sleep apnea.