Philips Respironics, Inc.: BiPAP A30 Ventilator, Part Number 1111143 (US and OUS) OUS Only: Part Numbers 1111144 1111145 1111147 1111148 1111149 1111150 1111154 1111181 1116155 1111144L 1111144M 11111

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: 3 US; 21,414 OUS Lot/code info: US distribution: Material No. 1111143 UDI-DI 00606959039308 Serial Numbers N182942836566 N14644718E852 N16489657EE4B -- OUS distribution: Material No. 1111143 UDI-DI 606959067493 Serial Nos. N09765363D900 N09765365BC36 N097653668EAD N097653679F24 N102712420C4C N102712431DC5 N1027125470A2 N10271255612B N1027125653B0 N10271258BACE N10271259AB47 N102712601CEE N102712610D67 N102712623FFC N102712632E75 N102712654B43 N1027126679D8 N1027126890A6 N102712700536 N1027127114BF N10271275529B N102712777189 N10271282A5EC N10271283B465 N10271285D153 N10271287F241 N102712880AB6 N102712891B3F N102712909F26 N10271292BC34 N10271293ADBD N10271294D902 N10271295C88B N10271297EB99 N10271298136E N1027129902E7 N1027130012E2 N10271307665D N102713089EAA N102713100B3A N102713122828 N102713155C97 N102713177F85 N1027131996FB N1027132313C9 N1027132576FF N10271329BC93 N102713356F27 N102713365DBC N102713374C35 N102713517DD3 N10271356096C N102713626520 N102713714E63 N102713727CF8 N10271390C5FA N10271410873F N1027141196B6 N10271413B5A4 N10271428211F N10271439294E N10271440F987 N10271442DA95 N10271443CB1C N102714496446 N10271473E174 N1027147495CB N102714758442 N10271476B6D9 N10271477A750 N102714794E2E N102714841603 N10271489CDE6 N102714926AED N102714951E52 N10271499D43E N10271503F6A0 N10271504821F N102715059396 N10271506A10D N10271511CC6A N10271513EF78 N1027151851AB N10271520F78B N10271521E602 N10271522D499 N10271523C510 N10271524B1AF N102715278334 N10271530EE53 N10271531FFDA N10271533DCC8 N102715368B65 N102715

UPC codes

00606959039308, 606959067493

Source

Official record: FDA (Device enforcement) ↗

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