Trilogy EV300, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients.
This recall is currently active, issued April 17, 2024. It was issued by Philips Respironics, Inc..
- Company
- Philips Respironics, Inc.
- Recall Initiated
- March 19, 2024
- Posted
- April 17, 2024
- Recall Number
- Z-1502-2024
- Quantity
- 56,012 units
- Firm Location
- Murrysville, PA
- Official Source
- View on FDA website ↗
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, ZA, ZW.
Lot / Code Info
Model No. BL2200X15B, BR2200X18B, CA2200X12B, EE2200X15B, EU2100X15B, EU2100X19, EU2200X15B, FR2200X14B, DE2200X13B, GB2200X15B, FX2100X15B, FX2200X15B, IN2100X15B, IN2100X19, IN2200X15B, IT2200X21B, JP2100X16B, KR2200X15B, LA2100X15B, ND2200X15B, ES2200X15B, TR2200X15B, DS2100X11B, DS2200X11B, UDI-DI: 606959058668, 606959058583, 606959052321, 606959058705, 606959055674, 606959055681, 606959058682, 606959058613, 606959058651, 606959058675, 606959061019, 606959061033, 606959054059, 606959055575, 606959056497, 606959058637, 606959055582, 606959058590, 606959055599, 606959058620, 606959058644, 606959058798, 606959051997, 606959052017; All units except those with software version 1.05.06.00.
Root Cause
Device Design
Action Taken
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.