Company: Philips Respironics, Inc.
Date of Enforcement Report: 9/4/2024
Class I
PRODUCT
Trilogy Evo EV300 — Model Number/ Model Description: BL2200X15B Trilogy Evo, O2, Benelux EV300; BR2200X18B Trilogy Evo, O2, Brazil EV300; CA2200X12B Trilogy Evo, O2, Canada EV300; DE2200X13B Trilogy Evo, O2, Germany EV300; DS2200X11B Trilogy Evo, O2, USA EV300; DS2200X11B Trilogy Evo, O2, USA EV300; EE2200X15B Trilogy Evo, O2, Eastern Europe EV300; ES2200X15B Trilogy Evo, O2, Spain EV300; EU2200X15B Trilogy Evo, O2, EU EV300; FR2200X14B Trilogy Evo, O2, France EV300; FX2200X15B Trilogy Evo, O2, INT EV300; GB2200X15B Trilogy Evo, O2, Great Britain EV300; IN2200X15B Trilogy Evo, O2, INTL EV300; IT2200X21B Trilogy Evo, O2, Italy EV300; KR2200X15B Trilogy Evo, O2, Korea EV300; ND2200X15B Trilogy Evo, O2, Nordics EV300; TR2200X15B Trilogy Evo, O2, Turkey EV300.
Recall Number:
Z-2942-2024
REASON:
Firm has released a mandatory software update Version 1.05.10.00 and a User Manual addendum for affected ventilators. These updates resolve safety issues identified in earlier recalls.
RECALLING FIRM/MANUFACTURER:
Philips Respironics, Inc.
VOLUME OF PRODUCT IN COMMERCE:
90,910 US; 56,273 ROW
DISTRIBUTION:
Worldwide distribution: US (nationwide) and OUS (foreign) countries of: AU, BD, BE, BG, BO, BR, BS, CH, CL, NL, CN, CO, CZ, DE, DK, FR, SE, GB, GF, GR, GT, HK, HR, HU, IE, IL, IN, IT, JP, KE, KW, LB, LT, MA, ME, MA, MT, MQ, MX, NO, NP, OM, PA, PE, PF, PK, PL, PT, PY, QA, RE, RO, RS, RU, SA, SE, SI, SK, SG, TH, TN, TR, TW, UA, YT, ZA and ZW.
