Recall Z-2289-2021 ยท NOU Continuous, Ventilator, Home Use
Philips Respironics, Inc.
Trilogy EV300, Product numbers CA2200X12B, DS2200X11B, FX2200X15B, IN2200X15B
| Date | Jul 26, 2021 |
| Status | Open, Classified |
| Reason | Two software issues have been identified related to pressure increase in the device: The first issue is described as "Infant/Pediatric EFS Calibration Pressure Increase" and the second issue is described as "Pressure Drift (Continuous Usage). |
| Root cause | Labeling design |
| Action | On July 26, 2021, the firm issued Urgent Medical Device Correction letters to affected customers. Customers were advised of the two software issues that the firm had identified related to pressure increase. Customers received guidance on how to identify affected products: Devices with software versions devices with software versions 1.02.01.00, 1.03.05.00, 1.03.07.00, 1.04.02.00, 1.04.06, 1.05.01 and 1.06.02 are impacted. Customers were provided with actions to take until the upcoming software fix is implemented on your device. Philips will be releasing a software correction to resolve this |
| Quantity | 18936 (US); 4659 (OUS) |
| Distribution | Worldwide distribution - US nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K181166 | Trilogy Evo Respironics, Inc., Jul 18, 2019 |