Philips Respironics, Inc.: BiPAP V30 Auto Ventilator. Intended to provide non-invasive ventilatory support for pediatric and adult patients weighing over 10 kg.

Hazard

This device does not indicate for use in patients with respiratory failure.

Details from the source

Reason for recall: This device does not indicate for use in patients with respiratory failure. Distribution: Worldwide distribution: US (Nationwide)including Guam and Puerto Rico; OUS (Foreign) to countries of: United Arab Emirates (AE), Argentina (AR), Austria (AT), Australia (AU), Bosnia and Herzegovina (BA), Belgium (BE), Brazil (BR), Canada (CA), Chile (CL), China (CN), Colombia (CO), Costa Rica (CR), Germany (DE), Denmark (DK), Spain (ES), France (FR), United Kingdom (GB), Hong Kong (HK), Hungary (H Quantity: 5,958 units Lot/code info: Part Number 1111178; UDI: 0060959049635; Serial No. 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, N2053456

UPC codes

0060959049635

Source

Official record: FDA (Device enforcement) ↗

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