Recall Z-1501-2024 ยท CBK Ventilator, Continuous, Facility Use
Philips Respironics, Inc.
LifeVentEVO2, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients. (sold outside US)
| Date | Apr 17, 2024 (initiated Mar 19, 2024) |
| Status | Open, Classified |
| Reason | Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power. |
| 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 not |
| Quantity | 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K181166 | Trilogy Evo Respironics, Inc., Jul 18, 2019 |