In June 2021, Philips Respironics issued a voluntary recall for specific ventilators, bi-level positive airway pressure and continuous positive airway pressure machines due to device breakage that could lead to patient injury. Yesterday, CDRH proposed that an order be issues to require the company to submit a plan to repair, replace or refund the purchase price of devices affected by this recall (and manufactured after November 2015).
“Philips has an opportunity for an informal hearing before the FDA determines whether to issue an order requiring Philips to submit a plan for the repair, replacement or refund of the purchase price (less a reasonable allowance for use if the device has been in possession of the user for one year or more). This proposal is in addition to the FDA’s previous action under section 518(a) to require Philips to provide notification to customers of the recall and the health risks presented by the recalled devices. We will continue to update the public about the status of this recall and share more information when it becomes available.” – FDA
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