FDA Device recall Z-1501-2024

LifeVentEVO2, all software versions except 1.05.06.00

FDA Device
Class I
ongoing
Published 2024-04-24

On 2024-04-24 the FDA classified a Class I recall of LifeVentEVO2, all software versions except 1.05.06.00 by Philips Respironics, citing potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-1501-2024
Classification	Class I
Status	ongoing
Initiated	2024-03-19
Published	2024-04-24
Last updated	2026-09-13 11:57 UTC
Company	Philips Respironics
Distribution	US

Product

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

Reason

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

Identifiers

code_info	Model No. SP2100X26B, UDI-DI: 606959057456; Serial No. H25691987749F, H25693118A4C4, H26260563C38D, H272315740BD0, H275… 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,

code_info

Model No. SP2100X26B, UDI-DI: 606959057456; Serial No. H25691987749F, H25693118A4C4, H26260563C38D, H272315740BD0, H275…

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,

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1501-2024%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.