Aug

2021

Recall – Ventilator experiences unexpected pressure drift

Company: Philips Respironics, Inc.
Date of Enforcement Report: 8/25/2021
Class II

PRODUCT

Trilogy Evo, Product numbers:

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

Recall Number: Z-2287-2021

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/MANUFACTURER

Philips Respironics, Inc. on 7/26/2021. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

18588 (US); 5662 (OUS)

DISTRIBUTION

U.S. Nationwide and International

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Recall – Ventilator experiences unexpected pressure drift

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