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周四 25 6月 2026
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SFDA Issues Safety Alert on Sleep Apnea Medical Devices
2024-02-21
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)
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Affected Models |
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Trilogy200 Ventilator |
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Trilogy100 Ventilator |
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BiPAP A40 Ventilator International |
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BiPAP A30 Ventilator International |
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BiPAP A40 Ventilator International |
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BiPAP S/T C Series International 30 |
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BiPAP AVAPS C Series International 30 |
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REMstar Plus C-Flex CPAP System |
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REMstar Pro C-Flex+ CPAP System |
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REMstar Auto A-Flex CPAP System |
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BiPAP Pro Bi-Flex BiPAP System |
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BiPAP Auto Bi-Flex BiPAP System |
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BiPAP autoSV ADV SYS ONE 60 Series INT |
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DreamStation BiPAP ST |
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DreamStation BiPAP ST |
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DreamStation BiPAP AVAPS |
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DreamStation BiPAP AVAPS |
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DreamStation BiPAP autoSV |
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DreamStation CPAP Pro |
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DreamStation Auto CPAP |
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DreamStation BiPAP Pro |
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DreamStation Auto BiPAP |
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DreamStation Go Auto CPAP with Bluetooth® |
|
OmniLab Advanced + System |
Warning date
2022-03-15
Manufacturing Country
United States
Reason for warning
A problem related to the sound-reducing material used in the device
Corrective actions
lnspect/replace the affected medical device accordance to the models mentioned in the safety alert
Consumer Tips
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
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