Skip to main content

SFDA Issues Safety Alert on Sleep Apnea Medical Devices

Warning Date
    2022-03-15
Manufacture Country

United States

Manufacture Company

Philips Respironics

Warning Reason

A problem related to the sound-reducing material used in the device 

 

Correction Actions

    lnspect/replace the affected medical device accordance to the models mentioned in the safety alert 

Advices to Consumer

    SFDA urge all users of these affected models to contact the authorized representative to inspect/replace the devices by calling the direct line 800-814-0039

SFDA Issues Safety Alert on Sleep Apnea Medical Devices

2022-03-15

Saudi Food and Drug Authority (SFDA) has issued a safety alert on the continuous positive airway pressure (CPAP) devices for the treatment of sleep apnea, manufactured by Philips Respironics in the United States of America .
SFDA stated that the affected medical devices, which included a problem related to the sound-reducing material used in it, are the devices that were manufactured before April 26, 2021, which included 24 affected models.
SFDA urge users of these affected models to contact the authorized representative of Philips Respironics to complete the corrective action and thinspect / replace it by calling e direct line 8008140039.
SFDA advises medical devices' users to report any incident/adverse events or problems suspected of being related to medical devices through SFDA’s reporting channels which are: 

Unified call center on the number (19999)

 

Affected Models

Trilogy200 Ventilator

Trilogy100 Ventilator

BiPAP A40 Ventilator International

BiPAP A30 Ventilator International

BiPAP A40 Ventilator International

BiPAP S/T C Series International 30

BiPAP AVAPS C Series International 30

REMstar Plus C-Flex CPAP System

REMstar Pro C-Flex+ CPAP System

REMstar Auto A-Flex CPAP System

BiPAP Pro Bi-Flex BiPAP System

BiPAP Auto Bi-Flex BiPAP System

BiPAP autoSV ADV SYS ONE 60 Series INT

DreamStation BiPAP ST

DreamStation BiPAP ST

DreamStation BiPAP AVAPS

DreamStation BiPAP AVAPS

DreamStation BiPAP autoSV

DreamStation CPAP Pro

DreamStation Auto CPAP

DreamStation BiPAP Pro

DreamStation Auto BiPAP

DreamStation Go Auto CPAP with Bluetooth®

OmniLab Advanced + System

Medical Devices
  • To report sector-related issues

  • Call Centre 19999


Other Warnings