Philips Respironics, Inc. Recall 88333
Description: Trilogy Evo Universal, Product number DS2000X11B
Philips Respironics, Inc. Recall 88333 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2290-2021 |
| Event ID | 88333 |
| Event Description | Trilogy Evo Universal, Product number DS2000X11B |
| Product Type | Devices |
| Distribution | Worldwide distribution - US nationwide distribution. |
| Quantity | 10,000 (FEMA Stockpile Only) |
| Recall 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). |
| Device Classification | 20210825 |
| Device Code Info | Software version numbers 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 |
| Center Classification Date | 20210813 |
| Recall Initiation Date | 20210726 |
| Recalling Firm | Philips Respironics, Inc. |
| Initial Notification | Letter |
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