Recall Z-1287-2023 ยท CBK Ventilator, Continuous, Facility Use
Philips Respironics, Inc.
Trilogy Evo O2 and LifeVentEVO2 Portable Electric Ventilator, Model Numbers DS2100X11B, IN2100X15B, IN2100X19, FX2100X15B, JP2100X16B, AU2100X15B, LA2100X15B, CA2100X12B, CN2100X17B, BR2100X18B, KR2100X15B, IA2100X15B, PP2100X10, FP2100X10, FR2100X14B, ND2100X15B, IT2100X21B, ES2100X15B, DE2100X13B, BL2100X15B, GB2100X15B, EU2100X15B, EU2100X19, EE2100X15B, TR2100X15B, UDS2100X11B, RDS2100X11B, an
| Date | Apr 3, 2023 (initiated Mar 1, 2023) |
| Status | Open, Classified |
| Reason | The accuracy of delivered oxygen may deviate below the required tolerance of 5% from setpoint when providing high concentration oxygen therapy. Additionally, if equipped, the internal FiO2 sensor may indicate a value higher than the device is actually delivering. This may lead to under delivery of oxygen. |
| Root cause | Under Investigation by firm |
| Action | An URGENT Medical Device Correction notification letter dated 3/1/23 was sent to customers. Actions that should be taken by the user in order to prevent risks for patients. Until a solution is provided by Philips Respironics, patients prescribed Trilogy EV300, Trilogy Evo O2, or Trilogy Evo Universal that use high pressure oxygen, the following precautions must be observed: 1. Continuously monitor oximetry (SpO2) of the patient and follow your institution s protocol for monitoring of arterial blood gas measurements to ensure that the patient is receiving adequate oxygenation. 2. Use an ex |
| Quantity | 62,826 total devices |
| Distribution | Worldwide distribution. US Nationwide including Puerto Rico, and countries of AE, AR, AT, AU, BD, BE, BG, BO, BR, CA, CH, CL, CN, CO, CZ, DE, DK, EC, EE, EG, ES, FI, FR, GB, GE, GT, HK, HR, HU, ID, IL, IE, IN, IT, JP, KW, LB, LT, MM, MQ, MX, MY, NG, NL, NO, NP, NZ, PE, PF, PH, PK, PL, PT, QA, RO, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K181166 | Trilogy Evo Respironics, Inc., Jul 18, 2019 |