Philips Respironics, Inc.: Medical Device Recall in 2021 - (Recall #: Z-2289-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

Trilogy EV300, Product numbers CA2200X12B, DS2200X11B, FX2200X15B, IN2200X15B

Product Classification:

Class II

Date Initiated: July 26, 2021

Date Posted: August 25, 2021

Recall Number: Z-2289-2021

Event ID: 88333

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).

Status: Ongoing

Product Quantity: 18936 (US); 4659 (OUS)

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

Distribution Pattern:

Worldwide distribution - US nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated