# FDA recall Z-2944-2024

> **Philips Respironics, Inc.** · Class I · device recall initiated 2024-07-16.

## Product

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  IT

## 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.

## 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.

## Key facts

- **Recall number:** Z-2944-2024
- **Recalling firm:** Philips Respironics, Inc.
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-07-16
- **Report date:** 2024-09-11

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Murrysville, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2944-2024

## Citation

> AI Analytics. FDA recall Z-2944-2024. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-2944-2024. Source: US FDA. Licensed CC0.

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