Philips Respironics, Inc.: BiPAP V30 Auto Ventilator, Part Number 1111178

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: 5,958 US; None OUS Lot/code info: UDI-DI 00606959049635 Serial Numbers N2068642229E4 N206864244CD2 N206864255D5B N206864277E49 N2068642886BE N206864299737 N2068643102A7 N20686432303C N2068643321B5 N20686434550A N206864354483 N206864367618 N206864376791 N206864389F66 N206864398EEF N206864405E26 N206864414FAF N206864427D34 N206864441802 N20686445098B N206864463B10 N206864472A99 N20686448D26E N20686449C3E7 N2068645047FE N206864515677 N2068645264EC N206864537565 N2068645401DA N206864551053 N2068645622C8 N206864573341 N20686458CBB6 N206864606D96 N206864617C1F N206864624E84 N206864635F0D N206864653A3B N2068646608A0 N2070799636A7 N20708029041F N20708103C229 N20708105A71F N2070811974AB N20708120C302 N20708137AE65 N20708141865B N20708147E36D N20713207A038 N20713212EE4D N207132184117 N20713222C425 N20713232DDFD N2071323872A7 N20713245E44A N207132582677 N20713270998F N207132810BCE N2071329445BB N2071329666A9 N207132977720 N207132988FD7 N207132999E5E N20713309139A N20713314D1A7 N207133190A42 N20713327C954 N207133328721 N2071333396A8 N2071335695D5 N20713363E810 N2071337594FE N20713377B7EC N2071338625AD N207133972DFC N207134088E16 N207134099F9F N207134145DA2 N207134212067 N2071342654D8 N207134375C89 N20713442462C N2071344357A5 N207134507CE6 N207134726C44 N2071347518FB N207134762A60 N20713478C31E N207134859B33 N205345571B7A N20534558E38D N20534559F204 N2053456045AD N2053456266BF N205345637736 N205345640389 N205345651200 N20534566209B N205345673112 N20534568C9E5 N20534569D86C N205345705C75 N205345714DFC N205345727F67 N205345

UPC codes

00606959049635

Source

Official record: FDA (Device enforcement) ↗

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