Recall of Philips and Löwenstein CPAP devices and ventilators

Since June 2021, Philips has been replacing ventilators and CPAP (continuous positive airway pressure) devices in several countries following the identification of a potential issue with the sound abatement foam used in these medical devices.

Philips ventilators and CPAP devices, which are mainly used at home, are used by patients with sleep apnoea or who require respiratory assistance.

PHILIPS devices affected

• Continuous positive airway pressure (CPAP): REMstar Pro, Auto, Expert (DreamStation, PR1/SystemOne, Q-series), BiPAP Auto, DreamStation Go
• Ventilators, life-supporting: Trilogy100 and Trilogy200
• Ventilators, non-life supporting: BiPAP autoSV (DreamStation, Advanced, PR1/SystemOne,C-series), BiPAP S/T and AVAPS (DreamStation, PR1, C-series) Omnilab Advanced+, BiPAP A30, BiPAP A40, BiPAP SOH)

All of the above devices manufactured before 26 April 2021 are affected.

The delays in implementing this corrective action are due to the fact that Philips has been unable to repair or replace all affected devices given the enormous scale of the recall, which has affected several countries and millions of patients. All devices ought to be replaced by June 2023 at the latest according to the updates from the manufacturer.

LÖWENSTEIN devices affected

In Luxembourg, the devices affected by this issue are mainly sold under the Löwenstein Medical SE & Co. KG brand.

The devices are the CPAP Phoenix 3(i) and Somnia 3(i).

The manufacturer has undertaken to ensure that all patients are provided with a replacement device or have their device repaired. This action is still ongoing, with around 20 new devices becoming available each week.

What should patients do

We recommend that you consult with your doctor and do not suddenly stop your treatment, regardless of the type of device used.

Your device will be repaired or replaced by your healthcare provider according to availability. Patients should report the serial number to the manufacturer in order to arrange an exchange.

www.philips.com/c-w/corporate-homepage/src-update

If you experience headaches, irritation (skin, eyes, respiratory tract), inflammatory reactions, coughing, chest pressure, asthma, sinus infection, or other symptoms that may be related to the use of the device, contact your doctor.

If you experience any such adverse effects, please also report the incident to the manufacturer or on the Santé.lu website (https://sante.public.lu/en/espace-professionnel/domaines/pharmacies-et-medicaments/dispositifs-medicaux.html), including the device's full serial number (your doctor will be able to help you submit this declaration).

In the event that you need additional specific support from the DPM in dealing with the manufacturers, please contact us via email at meddevices.vigilance@ms.etat.lu, including incident reports from healthcare professionals, users, and patients.