Recall Announcement

IMPORTANT NOTE To our patients on a Sleep Apnea Positive Airway Pressure Device and Patients on Mechanical Ventilation

Philips Respironics announced a voluntary recall for Continuous and Non-Continuous Ventilators (certain CPAP, BiLevel PAP and Ventilator Devices) due to two issues related to the polyester-based polyurethane (PE-PUR) sound abatement foam used in these devices. For information on the Recall Notice, a complete list of impacted products, and potential health risks, visit philips.com/src-update.

The recall notification advises patients and customers to take the following actions:

• For patients using BiLevel PAP and CPAP devices:
  Discontinue use of affected units and consult with physicians to determine the benefits of continuing therapy and potential risks.
• For patients using life-sustaining mechanical ventilator devices: DO NOT discontinue or alter prescribed therapy, without consulting physicians to determine appropriate next steps.
• 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.

Please contact our office with any questions by calling:
610-685-5864 and press 3 for nursing or 5 for DME referral staff