Philips statement on recent media article related to Philips Respironics’ voluntary recall notification/field safety notice

Philips’ first priority is patient safety and quality. We understand how important Philips Respironics’ sleep therapy devices and ventilators are to patients that use them and how they improve their lives every day and night. We regret the distress and concern that the June 2021 recall notification/field safety notice has caused for patients and care providers. We deeply apologize for that and continue to work hard to resolve this for our patients and customers.

We would like to emphasize that in April 2021, Philips’ understanding of the component quality issue and the potential mitigating actions was still progressing. As part of the technical investigation, Philips Respironics took precautionary measures, including stopping the manufacturing and selling of sleep therapy devices to its distributors and customers.

At that time and pending the conclusion of the technical investigation, Philips Respironics’ ship hold decision would not extend to devices already in the possession and control of distributors and customers. In the absence of an authorized recall, Philips Respironics was not in a position to communicate to its distributors and customers to halt distributing devices.

A ship hold is a common industry process used by manufacturers to halt shipments of products with a potential issue to distributors and customers. This allows the company time to do a thorough technical investigation of the potential issue and to determine if further actions are necessary, including the potential for a recall.

When additional data and further analyses became available and after alignment with the relevant regulators and competent authorities, including the FDA, Philips Respironics initiated the recall in June 2021. The recall involved the global repair and replacement of the sleep therapy and ventilator devices under the recall.

Completing this recall remains our highest priority, with the remediation of the sleep therapy devices almost complete and remediation of the ventilators ongoing. Globally, over 99% of the sleep therapy device registrations that are complete and actionable have been remediated.