(Reuters) – The U.S. Food and Drug Administration (FDA) asked Dutch medical equipment maker Philips Respironics on Thursday to notify patients about the company’s recall of certain ventilators and other breathing assistance machines in June last year.
FDA said in a statement that it had determined the order necessary, citing the risk of harm posed by the recalled products.
“Taking this action today enables the FDA to mandate that Philips Respironics improve its communication about the recall and the serious risk posed by the foam used in the recalled products with patients,” the regulator added.
The company said in a statement it would be working with its durable medical equipment (DME) customers to allow the company to directly contact those patients and other end-users that may not yet have received notice of the recall.
Philips Respironics had recalled some breathing devices and ventilators in June last year because of a foam part that might degrade and become toxic, potentially causing cancer.
The health regulator has also recommended the company to provide monthly updates to device users that include information on expected time for replacement and current rate of replacement of recalled devices.
(Reporting by Akanksha Khushi and Vishal Vivek in Bengaluru; Editing by Rashmi Aich)
