Z-2290-2021 Class II Ongoing
FDA device recall Z-2290-2021 was initiated by Philips Respironics, Inc. on July 26, 2021 and is designated Class II. Reason for recall: 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 descri… The recall status is ongoing. Affected quantity: 10,000 (FEMA Stockpile Only).
Recall Details
- Product Type
- Devices
- Report Date
- August 25, 2021
- Initiation Date
- July 26, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10,000 (FEMA Stockpile Only)
Product Description
Trilogy Evo Universal, Product number DS2000X11B
Reason for Recall
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).
Distribution Pattern
Worldwide distribution - US nationwide distribution.
Code Information
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