Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
BiPAP A40 Ventilators: BiPAP A40 Recalled by Philips Respironics, Inc. Due to Potential for devices to experience interruption/loss of therapy...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Philips Respironics, Inc. directly.
Affected Products
BiPAP A40 Ventilators: BiPAP A40, Part Numbers 1111169 (US and OUS) and (OUS ONLY)1111170 1111171 1111173 1111174 1111175 1111177 1116156 1111170S BR1111169 CN1111169 IT1111169 R1111169 R1111177 R1116156 ; BiPAP A40 Pro, Part Numbers (OUS Only): ARX3100S19 AUX3100S19 BLX3100S19 BRX3100S18 CAX3100S12 CAX3100T12 DEX3100S13 EEX3100S19 ESX3100S19 FRX3100S14 GBX3100H19 GBX3100S19 IAX3100S19 INX3100H19 INX3100S19 ITX3100S21 SPX3100S19 ; BiPAP A40 EFL, Part Numbers (OUS Only): AUX3000S19 DEX2900S13 DEX3000S13 EEX3000S19 ESX3000S19 FRX3000S14 GBX3000S19 INX3000H19 ITX3000S21
Quantity: 6 US, 60,417 OUS
Why Was This Recalled?
Potential for devices to experience interruption/loss of therapy during a Ventilator Inoperative alarm. This may lead to hypoventilation, mild to severe hypoxemia, hypercarbia, respiratory failure/insufficiency, or potentially death in the most vulnerable patients.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Philips Respironics, Inc.
Philips Respironics, Inc. has 85 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report