Z-1501-2024Class I

LifeVentEVO2, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients. (sold...

Name: Z-1501-2024 LifeVentEVO2, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients. (sold...
Creator: Philips Respironics, Inc.
Published: 2024-03-19
License: https://open.fda.gov/license/

Respironics, Inc. / initiated 2024-03-19 / Open, Classified / root cause: design

FDA source

Philips Respironics, Inc. began a recall of LifeVentEVO2, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients. (sold outside US) on 2024-03-19. FDA classified it as Class I and gives the reason as "Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1501-2024
Classification: Class I
Status: Open, Classified
Initiated: 2024-03-19
Posted: 2024-04-17
Recalling firm: Respironics, Inc.
Product: LifeVentEVO2, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients. (sold outside US)
Product code: CBK Ventilator, Continuous, Facility Use
Reason for recall: Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power.
Root cause tag: design
FDA root cause: Device Design
Action: Consignees were mailed an URGENT MEDICAL DEVICE CORRECTION notice, dated 3/7/24. Consignees are asked to identify any affected product in their inventory and follow the provided instructions in order to continue using devices safely in CPAP or PSV mode. Devices that alarm are to be immediately plugged into a power source if a Loss of Power Alarm occurs. If no source of power is available, remove and replace the detachable battery. Devices running on software other than 1.05.06.00 can be updated to the latest software version, which does not experience this failure mode. The provided recall notice should be shared with all members of consignee organizations that utilize the recalled devices. If product was further distributed the provided notice should be forwarded. Consignees with any questions can contact Philips Respironics Customer Service at 1-800-345-6443 for homecare customers or 1-800-722-9377 for hospital customers.
Quantity in commerce: 1,002 units
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, ZA, ZW.
Product codes and lots: 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, 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H80017466DF49, H80017467CEC0, H800174683637, H8001746927BE, H80017473913C, H800174921AA5, H800175128EB9, H80017514EB8F, H80018072512D, H80018139D242, H800181433010, H800181455526, H8001814667BD, H800181499F4A, H800181523841, H800181545D77, H800181554CFE, H800181576FEC, H80018158971B, H800181598692, H8001816120B2, H800181621229, H80018164771F, H800181656696, H80018166540D, H80018168BD73, H80018169ACFA, H80018171396A, H800181720BF1, H800181731A78, H800181746EC7, H800181764DD5, H800181775C5C, H80018178A4AB, H80018179B522, H80018181BAA2, H8001818399B0, H80018184ED0F, H800181882763, H8001818936EA, H80018190B2F3, H80018191A37A, H8001819291E1, H800181938068, H80018195E55E, H800181983EBB, H800181992F32, H800182008A8F, H80018202A99D, H8001820806C7, H80018209174E, H80018212B045, H80018254B213, H8001826589F2, H80018275902A, H800182784BCF, H80018284026B, H80018300D053, H8001830587FE, H800183085C1B, H800183094D92, H80018310C98B, H80018311D802, H80018313FB10, H800183159E26, H80018316ACBD, 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H800184908B4E, H800184919AC7, H80018492A85C, H80018493B9D5, H80018494CD6A, H80018495DCE3, H80018496EE78, H80018497FFF1, H800184980706, H800185011703, H800185033411, H8001850440AE, H800185176BED, H800185198293, H80018538A0AA, H8001854061EA, H800185435371, H80018548EDA2, H80018630C386, H80018633F11D, H8001863485A2, H80018636A6B0, H80018637B739, H800186395E47, H800186408E8E, H800186419F07, H80018642AD9C, H80018643BC15, H80018644C8AA, H80018645D923, H80018646EBB8, H80018647FA31, H8001864802C6, H80018649134F, H800186509756, H8001865186DF, H80018652B444, H80018653A5CD, H80018654D172, H80018655C0FB, H80018656F260, H800186581B1E, H80018660BD3E, H80018661ACB7, H80018665EA93, H80018666D808, H80018667C981, H800186683176, H80018671B56F, H80018673967D, H80018675F34B, H80018677D059, H8001883495B9, H800188394E5C, H80018855D0E0, H80018856E27B, H800188591A8C, H80018860AD25, H80018861BCAC, H800188628E37, H800188639FBE, H80018864EB01, H80018865FA88, H80018866C813, H80018867D99A, H80018868216D, H80018871A574, H8001887297EF, H800188738666, H80018874F2D9, H80018875E350, H80018876D1CB, H8001887838B5, H80018879293C, H8001888126BC, H80018961E670, H800189696A38, H262606335251, H8000950100FC, H80017076A5F0, H800172887AFE, H80018322C0F1, H80018499168F.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1501-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1499-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-04-24	2024-04-17
Z-1500-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-04-24	2024-04-17
Z-1501-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-04-24	2024-04-17
Z-1502-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-04-24	2024-04-17
Z-1503-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-04-24	2024-04-17
Z-1504-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-04-24	2024-04-17
Z-1505-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-04-24	2024-04-17

Product code CBK

K181166Class IITrilogy EvoRespironics, Inc. / cleared 2019-07-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)