PlainRecalls
FDA Devices Critical Class I Ongoing

Trilogy Evo; Model No./Model Description -- AU2110X15B Trilogy Evo, Australia BL2110X15B Trilogy Evo, Benelux BR2110X18B Trilogy Evo, Brazil CA2110X12B Trilogy Evo, Canada DE2100X13B Trilogy Evo O2, Germany DE2110X13B Trilogy Evo, Germany DS2100X11B Trilogy Evo, O2, USA DS2110X11B Trilogy Evo, USA DS2110X11B Trilogy Evo, USA EE2100X15B Trilogy Evo O2, Eastern Europe EE2110X15B Trilogy Evo, Eastern Europe ES2100X15B Trilogy Evo O2, Iberia ES2110X15B Trilogy Evo, Iberia EU2100X15

Reported: September 11, 2024 Initiated: July 16, 2024 #Z-2944-2024

Product Description

Trilogy Evo; Model No./Model Description -- AU2110X15B Trilogy Evo, Australia BL2110X15B Trilogy Evo, Benelux BR2110X18B Trilogy Evo, Brazil CA2110X12B Trilogy Evo, Canada DE2100X13B Trilogy Evo O2, Germany DE2110X13B Trilogy Evo, Germany DS2100X11B Trilogy Evo, O2, USA DS2110X11B Trilogy Evo, USA DS2110X11B Trilogy Evo, USA EE2100X15B Trilogy Evo O2, Eastern Europe EE2110X15B Trilogy Evo, Eastern Europe ES2100X15B Trilogy Evo O2, Iberia ES2110X15B Trilogy Evo, Iberia EU2100X15B Trilogy Evo, O2, EU EU2100X19 Trilogy Evo, O2, EU (Non-BT) EU2110X15B Trilogy Evo, EU EU2110X19 Trilogy Evo, EU (Non-BT) FR2100X14B Trilogy Evo O2, France FR2110X14B Trilogy Evo, France FX2100X15B Trilogy Evo, O2, INT GB2110X15B Trilogy Evo, Great Britain IA2100X15B Trilogy Evo O2, India IA2110X15B Trilogy Evo, India IN2100X15B Trilogy Evo, O2, International IN2100X19 Trilogy Evo, O2, International (Non-BT) IN2110X15B Trilogy Evo, International IT2100X21B Trilogy Evo O2, Italy IT2110X21B Trilogy Evo, Italy JP2100X16B Trilogy Evo, O2, Japan JP2110X16B Trilogy Evo, Japan KR2110X15B Trilogy Evo, Korea LA2100X15B Trilogy Evo, O2, Latin America LA2110X15B Trilogy Evo, Latin America LD2110X23B Garbin Evo, Linde ND2100X15B Trilogy Evo O2, Nordics ND2110X15B Trilogy Evo, Nordics RDS2110X11B Trilogy Evo, USA-Rental SP2100X26B LifeVentEVO2 TR2110X15B Trilogy Evo, Turkey UDS2110X11B Trilogy Evo, USA-RECERT VT2110X24B Aeris EVO

Reason for Recall

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.

Details

Recalling Firm
Philips Respironics, Inc.
Units Affected
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.
Location
Murrysville, PA

Frequently Asked Questions

What product was recalled?
Trilogy Evo; Model No./Model Description -- AU2110X15B Trilogy Evo, Australia BL2110X15B Trilogy Evo, Benelux BR2110X18B Trilogy Evo, Brazil CA2110X12B Trilogy Evo, Canada DE2100X13B Trilogy Evo O2, Germany DE2110X13B Trilogy Evo, Germany DS2100X11B Trilogy Evo, O2, USA DS2110X11B Trilogy Evo, USA DS2110X11B Trilogy Evo, USA EE2100X15B Trilogy Evo O2, Eastern Europe EE2110X15B Trilogy Evo, Eastern Europe ES2100X15B Trilogy Evo O2, Iberia ES2110X15B Trilogy Evo, Iberia EU2100X15B Trilogy Evo, O2, EU EU2100X19 Trilogy Evo, O2, EU (Non-BT) EU2110X15B Trilogy Evo, EU EU2110X19 Trilogy Evo, EU (Non-BT) FR2100X14B Trilogy Evo O2, France FR2110X14B Trilogy Evo, France FX2100X15B Trilogy Evo, O2, INT GB2110X15B Trilogy Evo, Great Britain IA2100X15B Trilogy Evo O2, India IA2110X15B Trilogy Evo, India IN2100X15B Trilogy Evo, O2, International IN2100X19 Trilogy Evo, O2, International (Non-BT) IN2110X15B Trilogy Evo, International IT2100X21B Trilogy Evo O2, Italy IT2110X21B Trilogy Evo, Italy JP2100X16B Trilogy Evo, O2, Japan JP2110X16B Trilogy Evo, Japan KR2110X15B Trilogy Evo, Korea LA2100X15B Trilogy Evo, O2, Latin America LA2110X15B Trilogy Evo, Latin America LD2110X23B Garbin Evo, Linde ND2100X15B Trilogy Evo O2, Nordics ND2110X15B Trilogy Evo, Nordics RDS2110X11B Trilogy Evo, USA-Rental SP2100X26B LifeVentEVO2 TR2110X15B Trilogy Evo, Turkey UDS2110X11B Trilogy Evo, USA-RECERT VT2110X24B Aeris EVO. Recalled by Philips Respironics, Inc.. Units affected: 90,910 US; 56,273 ROW.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on September 11, 2024. Severity: Critical. Recall number: Z-2944-2024.