The recall notification (U.S. only) / field safety notice (International Markets) advises patients and customers to take the following actions:
For patients using BiLevel PAP and CPAP devices:
- Discontinue use of your device and work with your physician or Durable Medical Equipment (DME) provider to determine the most appropriate options for continued treatment.
For patients using life-sustaining mechanical ventilator devices:
- Do not stop or alter your prescribed therapy until you have talked to your physician. Philips recognizes that alternate ventilator options for therapy may not exist or may be severely limited for patients who require a ventilator for life-sustaining therapy, or in cases where therapy disruption is unacceptable. In these situations, and at the discretion of the treating clinical team, the benefit of continued usage of these ventilator devices may outweigh the risks.
- If your physician determines that you must continue using this device, use an inline bacterial filter. Consult your Instructions for Use for guidance on installation.
Philips is recommending that customers and patients halt use of ozone-related cleaning products, and adhere to their device Instructions for Use for approved cleaning methods.
Additionally, Philips is reminding customers and patients to review the age of their BiLevel PAP and CPAP devices, as they are typically recommended to be replaced after five years of use.