FDAFDA · Food and drugs·Recall number Z-1814-2024
BiPAP A30 Ventilator, Part Number 1111143 (US and OUS) OUS Only: Part Numbers 1111144 1111145 1111147 1111148 1111149 1111150 1111154 1111181 1116155 1111144L 1111144M 1111144V BR1111143 CN1111143 R1111143 R1111150 R1111181
Published May 29, 2024 · Recall initiated: March 26, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Philips Respironics, Inc.
- Distributor
- 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.
- Lot
- 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 N102715379AEC N102715397392 N102715428049 N1027154391C0 N10271547D7E4 N102715482F13 N10271550BA83 N10271551AB0A N102715538818 N10271554FCA7 N10271556DFB5 N10271557CE3C N1027156090EB N102715618162 N10271563A270 N10271565C746 N10271566F5DD N102715681CA3 N102715690D2A N102715708933 N1027157198BA N10271573BBA8 N10271576EC05 N102715811B72 N1027158229E9 N102715844CDF N102715855D56 N102715866FCD N102715877E44 N102715901323 N1027159102AA N1027159321B8 N102715967615 N102715998EE2 N102716002B5F N10271602084D N1027160319C4 N102716075FE0 N103072047177 N1030720560FE N103072065265 N10307208BB1B N103072120D99 N103072131C10 N103072164BBD N1030722004E3 N1030722442C7 N10307225534E N1030722661D5 N10307227705C N1030722888AB N1030728875DB N10307291F1C2 N10307295B7E6 N103072986C03 N103073024E9D N103073053A22 N103073107457 N10307331566E N10307338CBAF N10307400E18A N103079470D2A N10307948F5DD N10307949E454 N10307950604D N1030795171C4 N1030795352D6 N1030795537E0 N10307956057B N10307958EC05 N103079604A25 N1030796378BE N103079640C01 N103079651D88 N103079673E9A N103079714274 N103079736166 N1030797636CB N103079772742 N10390442A3BD N103904491D6E N10390453ABEC N10390454DF53 N10390461A296 N1039047289D5 N10390474ECE3 N10390478268F N103904793706 N10390480290F N103904820A1D N103904831B94 N10390488A547 N106383854F50 N106383876C42 N10638389853C N106383900125 N1063839333BE N10638408D670 N10638409C7F9 N1063841260F2 N10638413717B N106384217801 N106384224A9A N106384253E25 N106384271D37 N10638428E5C0 N106384325342 N106384343674 N1063843704EF N10638438FC18 N106384412CD1 N106384421E4A N106384447B7C N106384456AF5 N10638448B110 N10638449A099 N106384513509 N106384520792 N10638453161B N1063845462A4 N10638455732D N1063845641B6 N10638457503F N10638458A8C8 N1063846448CC N106384666BDE N106384699329 N1063847106B9 N106384723422 N1063847325AB N10638475409D N106384767206 N106384789B78 N1063848094F8 N10638482B7EA N107027350DD0 N107027363F4B N10702739C7BC N107027401775 N1070274325EE N1070274540D8 N107027489B3D N10712374131C N107124758E90 N1089483471E9 N110704849D3B N110704858CB2 N110706860B91 N110706871A18 N11070688E2EF N11070689F366 N11070690777F N1107069166F6 N1107069703C0 N11070700FABB N11070701EB32 N11070704BC9F N1107070876F3 N11070709677A N11070712C071 N11070715B4CE N1107071797DC N11070720C90B N11070721D882 N11070722EA19 N11070723FB90 N11081736C3A2 N11081737D22B N110817393B55 N11081741FA15 N11081742C88E N11081743D907 N11081744ADB8 N11081745BC31 N110817479F23 N1108174867D4 N11081749765D N11081750F244 N11081751E3C
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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