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