Philips Respironics, Inc.: OmniLab Advanced + Ventilator Product Numbers 1111122 1111123 1111124 1111125 1111126 1111127 1111138 1111141 1111142 KR1111127 R1111122 R1111123 R1111124 U1111122 U1111124

Hazard

Device may experience an interruption or loss of therapy in case of a Ventilator Inoperative alarm. This may lead to hypoventilation, mild to severe hypoxemia, hypercarbia, respiratory failure/insufficiency, or potentially death.

Details from the source

Reason for recall: Device may experience an interruption or loss of therapy in case of a Ventilator Inoperative alarm. This may lead to hypoventilation, mild to severe hypoxemia, hypercarbia, respiratory failure/insufficiency, or potentially death. Distribution: US Nationwide distribution and OUS International distribution to Canada. Quantity: 9,388 US; 2,664 ROW Lot/code info: Product Number / UDI-DI/ Serial Numbers: 1111122 / UDI-DI 606959067813 Serial Numbers L097964930206 L09796498BCD5 L09796510A481 L097965381B79 L0979657784EE L097965971EFE L09796767288E L09796779D828 L097968136965 L097968141DDA L097968163EC8 L09796818D7B6 L09796819C63F L097968225284 L09796823430D L0979682437B2 L09796825263B L097968270529 L09796829EC57 L0979684751F9 L09796849B887 L097968512D17 L097968521F8C L0981390546A9 L098140911CAA L098141339814 L100102519380 L10010275E614 L1001028123F8 L1001028565DC L1001028746CE L10010288BE39 L100102913A20 L100102975F16 L1001030394F6 L10010310BFB5 L100103138D2E L10010338004D L1001034596A0 L100103558F78 L1001039705CA L100104165686 L10010417470F L100104223ACA L100104300000 L103082023D42 L103905201559 L10638229B96A L1063826260D9 L106382750DBE L10638290C003 L106383073978 L106383114596 L1087900826E2 L10879015E4DF L11022823358F L1102293730AF L110456413EEF L110706047DB9 L110708377551 L11070894BABA L11070899615F L11070900715A L11070906146C L110709489A72 L110709500FE2 L11081466C984 L110815129874 L110815290CCF L110815669358 L110817023414 L11136407983B L112492807AC5 L11249288F68D L11249292400F L112492935186 L112492942539 L11249296062B L1124929717A2 L11249299FEDC L11249304A8FD L112493086291 L11249312D413 L122858118744 L12735071463D L12945235DBBF L1323076570C1 L13230766425A L1323076753D3 L13230768AB24 L13230769BAAD L1330033132DB L13300393ECB9 L186537949AFB L18653797A860 L21271600A5A0 L22035135ABA4 L22035136993F L220351387041 L2203513961C8 L22226897CF07

UPC codes

606959067813, 606959067820, 606959067837

Source

Official record: FDA (Device enforcement) ↗

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