A massive voluntary recall of Philips Respironics CPAP and BiPAP devices for sleep apnoea in June 2021 is still having repercussions. Affected devices had the potential to introduce harmful particulates to the system and endanger the patient so the FDA labelled the recall Class I and recommended patients stop using the devices immediately. According to the FDA, it has received more than 105,000 medical device reports (MDRs) related to the recall, including 385 reports of death, between April 2021 and March 2023. MDRs have limitations and are used by the FDA as an indicator of risk rather than a definitive evaluation of the root causes. The company has previously allocated costs to deal with the problem and projects a total cost of $606m. This recall impacts over 5.5 million devices from the Dreamstation and V60 product lines.
As a result of the scope of repair and rework necessitated by the recall, Philips stopped taking orders for new sleep therapy systems, continuing only replacement consumables. Philips has seen the global annual sales revenue in its connected care businesses, which includes sleep and respiratory care, drop by 20.5% from $6.04bn in 2020 to $4.80bn in 2022 and cites the recall as central to the decline.
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This has presented an opportunity for competing manufacturer ResMed to gain market share. While initially slow to capitalise due to the ubiquitous supply chain issues caused by the global pandemic, Resmed has made a concerted effort to meet the excess demand of the market. The global annual sales revenue for its Total Sleep and Respiratory Sales segment has seen a 22.3% increase from $2.60bn in 2020 to $3.18bn in 2022, with expectations of a strong supply chain in 2023.
Details of another Philips recall pertaining to 72,000 ventilators were posted by the FDA on August 15, 2023. This affects the Trilogy ventilators product line and while smaller in scope, it presents another obstacle to regaining consumer and regulator confidence for the company.
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