Philips Respironics, Inc.: Medical Device Recall in 2021 - (Recall #: Z-2287-2021)

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 Evo, Product numbers BL2110X15B, CA2110X12B, DE2110X13B, DS2110X11B, EE2110X15B, ES2110X15B, EU2110X15B, EU2110X19, FR2110X14B, GB2110X15B, IA2110X15B, IN2110X15B, IN2110X19, IT2110X21B, KR2110X15B, LA2110X15B, LD2110X23B, ND2110X15B, RDE2110X13B, UDS2110X11B

Product Classification:

Class II

Date Initiated: July 26, 2021

Date Posted: August 25, 2021

Recall Number: Z-2287-2021

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: 18588 (US); 5662 (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