Trilogy EV300, Product numbers CA2200X12B, DS2200X11B, FX2200X15B, IN2200X15B
FDA Recall Z-2289-2021 · Posted None
Recalling FirmPhilips Respironics, Inc.
Recall StatusOpen, Classified
Product CodeNOU
Date Initiated2021-07-26
Product Quantity18936 (US); 4659 (OUS)
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).
Firm 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 issue, and will contact customers when the software correction is released.
If you need any further information or support concerning this issue, please contact Philips Customer Care Solutions Center
Trilogy Evo: +1-800-345-6443 Option 2, Option 1 (Available 24/7)
Trilogy EV300: +1-800-722-9377 (Available 24/7)
Root Cause
Labeling design
Distribution Pattern
Worldwide distribution - US nationwide distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.