Recall Z-2290-2021— Philips Respironics, Inc.

Name: FDA recall Z-2290-2021
Creator: U.S. Food and Drug Administration
Published: 2021-07-26

Class II · Ongoing

Class II FDA medical device recall by Philips Respironics, Inc., initiated 2021-07-26. It names one FDA 510(k) clearance: K181170. Product: Trilogy Evo Universal, Product number DS2000X11B. Reason: 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)..

Recalling firm: Philips Respironics, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2021-07-26
Firm location: Murrysville, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K181170 — Trilogy Evo UniversalRespironics, Inc.·cleared 2019-07-18

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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).

Data sourced from openFDA. This site is unofficial and independent of the FDA.