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Open, Classified

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

FDA Recall Z-1501-2024 · Posted 2024-04-17

Recalling FirmPhilips Respironics, Inc.
Recall StatusOpen, Classified
Product CodeCBK
Date Initiated2024-03-19
Product Quantity1,002 units

Reason for Recall

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

Firm 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.

Root Cause

Device Design

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K181166Trilogy EvoRespironics, Inc. · 2019-07-18

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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