Philips Respironics, Inc.: BiPAP A40 Ventilators: BiPAP A40, Part Numbers 1111169 (US and OUS) and (OUS ONLY)1111170 1111171 1111173 1111174 1111175 1111177 1116156 1111170S BR1111169 CN1111169 IT1111

Hazard

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.

Details from the source

Reason for recall: 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. Distribution: Worldwide distribution. US Nationwide including PR and GU; Austria, Belgium, Cyprus, Czech Republic, Denmark, France, Germany, Hungary, Italy, Netherlands, Poland, Portugal, Romania, Serbia, Slovakia, Spain, and Turkey. Quantity: 6 US, 60,417 OUS Lot/code info: US: Material No. 1111169 UDI-DI 00606959039476 Serial Numbers V182393118CC9 V21942863DD70 V219429359C22 V25585948745C V26439189762A V2640770372E7 OUS: A40: Material No. 1111169 UDI-DI 00606959039476 Serial Numbers V09765327781A V09765332366F V097653405875 V097653436AEE V097653472CCA V0976535041AD V097653551600 V09765356249B V09765358CDE5 V100863961519 V10086398FC67 V10086399EDEE V100864020820 V10086408A77A V1008641032EA V100864112363 V100864130071 V1008641474CE V100864201882 V100864223B90 V100864276C3D V10086436646C V100864388D12 V100864399C9B V100864426F40 V100864437EC9 V100864462964 V10086448C01A V10086450558A V100864514403 V100864527698 V100864536711 V100864550227 V1008645630BC V10086459C84B V100864616E6B V100864634D79 V1008646439C6 V10086465284F V100864670B5D V10086468F3AA V1008643333C1 V1008647177B3 V100864724528 V100864771285 V10086478EA72 V10086479FBFB V1008648869BA V100864013ABB V100864267DB4 V100864451BFF V10086458D9C2 V100864625CF0 V100864753197 V10086484A3D6 V10086476030C V10086509EC2F V100865489AC6 V10086482C6E0 V1008643556F7 V100865124B24 V100865262768 V10086528CE16 V100865454123 V100864002B32 V100864415DDB V10086469E223 V1008650437CA V1008652370C5 V1008640319A9 V10086485B25F V10271624DE95 V10271625CF1C V10271627EC0E V1027162814F9 V102716290570 V102716308169 V1027163190E0 V10271633B3F2 V10271664B9F5 V102716943A3D V102716952BB4 V10271696192F V10271698F051 V10271699E1D8 V10271700F1DD V10271704B7F9 V1027170694EB V10271711F98C V10271712CB17 V10271713DA9E V10271714AE2

UPC codes

00606959039476

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.