Philips Respironics, Inc.: LifeVentEVO2, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients. (sold outside US)

Hazard

Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power.

Details from the source

Reason for recall: Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power. Distribution: Domestic: Nationwide Distribution; Foreign: AE, AR, AT, AU, BD, BE, BG, BO, BR, BS, CA, CH, CL, CN, CO, CZ, DE, DK, DZ, EC, EE, EG, ES, FI, FR, GB, GE, GF, GI, GR, GT, HK, HR, HU, ID, IE, IL, IN, IT, JE, JO, JP, KE, KR, KW, LB, LT, MA, ME, MK, MM, MQ, MT, MX, MY, NG, NL, NO, NP, NZ, OM, PA, PE, PF, PH, PK, PL, PR, PT, PY, QA, RE, RO, RS, RU, SA, SE, SG, SI, SK, TH, TN, TR, TW, UA, US, UY, VN, YT, Quantity: 1,002 units Lot/code info: Model No. SP2100X26B, UDI-DI: 606959057456; Serial No. H25691987749F, H25693118A4C4, H26260563C38D, H272315740BD0, H275461032A2A, H2754619843E1, H800113616C69, H8001868315B5, H80018684610A, H800186864218, H25960483860A, H25961937C742, H259841474367, H260431913B25, H262335860DA9, H262602020AD1, H262644950D43, H262646266EC8, H262646367710, H262646617D17, H263906254068, H2639077033A1, H26233895D995, H2623414968BE, H262563210770, H262563563EC7, H2626051921DF, H26261131E1FD, H26264428320E, H272679278F9E, H80017449140E, H26256349DFE8, H262563550C5C, H26264347122C, H26294981C73C, H26295055B1C5, H26295125A611, H2629623201DF, H262962357560, H262962641A51, H26345540BE52, H26375381CD6E, H2637608762F1, H263815582E1E, H263905899810, H2639068866FD, H2639071176F8, H2639071530DC, H26390733665A, H26687445E9E2, H27267903FA0A, H272680683EEE, H274533967E1F, H2745340372AF, H27455642FA64, H27455664ACE2, H27457409AF19, H274575466A52, H274575576203, H27457607F3DF, H27466494A293, H274664979008, H2746650178FA, H274665035BE8, H274674897C15, H274675106C10, H274675124F02, H274675135E8B, H2746751718AF, H274675204678, H2746761192FD, H274781970CB3, H27479224295F, H274793406177, H27479520E37E, H274795396767, H275437779988, H27543778617F, H2754377970F6, H275437806EFF, H275437817F76, H275437824DED, H275437835C64, H2754378428DB, H275437853952, H275437860BC9, H275437871A40, H27543788E2B7, H27543789F33E, H275437907727, H2754379166AE, H275437925435, H2754379345BC, H275437943103, H27543795208A, H275437961211, H2754

UPC codes

606959057456

Source

Official record: FDA (Device enforcement) ↗

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