Phillips Respironics Recall Information
Updated: August 23, 2021
Phillips Respironics has notified Fitzsimmons that they have started shipping certain replacement CPAP/ BiPAP units to patients with recalled units in the United States. According to Phillips, shipments of new units will occur by allotment to certain geographic areas. The recalled CPAP units will be replaced with either new model Dreamstation 2 or new Dreamstation units and certain Bilevel devices will be replaced with new Dreamstation units. Replacement units will have a new sound abatement foam that has been approved by the FDA.
Phillips Respironics has not shared how the replacement process works only to indicate that it is by allocation to geographic areas.
Due to an influx of questions, additional information is being provided about the use of bacteria filters with CPAP/BiLevel devices. According to FDA regulation 868.5260, bacteria filters are medical devices that are intended to remove microbiological and particulate matter from the gases in the breathing circuit. Philips does not recommend using bacteria filters outside of their normal intended use. Therefore, these bacteria filters should not be used on CPAP/BiLevel devices as a means of mitigating risk of PE-PUR foam chemical emission or particulate matter. See attached to learn more. Bacteria Filters can be used on Trilogy Ventilators.
On June 14, 2021, 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, please see link below. You can also visit www.philips.com/src-update or contact Phillips Respironics at (877) 907-7508 to learn more.
Please know that Fitzsimmons Home Medical Equipment takes patient safety seriously. We are closely working with Phillips Respironics to provide our patients with the most up to date information. Fitzsimmons has provided Phillips Respironics with pertinent patient information and letters are being mailed to all Fitzsimmons patients that are impacted by this recall.
- Recall Letter for Patients
- CPAP and BiLevel PAP Device Recall Letter
- Ventilator Recall Letter
- Begin Registration Process
- Questions and Answers by Phillips Respironics.
Once Phillips Respironics obtains regulatory approval for the repair and/or replacement program, Fitzsimmons will work with the manufacturer to expediate this process for our patients. At this time, Fitzsimmons has not received guidance to give our patients on the repair and/or replacement program.