Z-2288-2021 Class II Ongoing
FDA device recall Z-2288-2021 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: 101 (FEMA Stockpile Only); 21077 (OUS).
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
- 101 (FEMA Stockpile Only); 21077 (OUS)
Product Description
Trilogy Evo O2, Product numbers DE2100X13B, DS2100X11B, EE2100X15B, ES2100X15B, EU2100X15B, FR2100X14B, FX2100X15B, IA2100X15B, IN2100X15B, IN2100X19, IT2100X21B, JP2100X16B, LA2100X15B, ND2100X15B, RDE2100X13B, SP2100X26B
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