# FDA recall Z-0638-2024

> **Philips Respironics, Inc.** · Class II · device recall initiated 2023-11-27.

## Product

Trilogy Evo and Trilogy Evo O2  Material Numbers BL2110X15B  BR2110X18B  CA2110X12B  DE2100X13B  DE2110X13B  DS2100X11B  DS2110X11B  EE2100X15B  EE2110X15B  ES2100X15B  ES2110X15B  EU2100X15B  EU2100X19  EU2110X15B  FR2100X14B  FR2110X14B  FX2100X15B  GB2110X15B  IA2100X15B  IA2110X15B  IN2100X15B  IN2100X19  IN2110X15B  IT2100X21B  IT2110X21B  JP2100X16B  JP2110X16B  KR2110X15B  LA2100X15B  LA2110X15B  ND2110X15B  RDE2100X13B  RDE2110X13B  RDS2110X11B  RIN2100X15B  RIN2110X15B  RJP2100X16B  RJP2110X16B  UDS2110X11B

## Reason for recall

The following was missing from the Contraindications Statement: The AVAPS-AE therapy mode is contraindicated for invasive use and patients less than 10 kg.   The AVAPS feature is contraindicated for patients less than 10 kg.    Potential harms if devices are used on contraindicated patients include barotrauma, hypoventilation/hypercapnia, and rebreathing of excessive CO2.

## Distribution

Worldwide distribution: US (nationwide)-AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, Including PR; and OUS (International) including countries of: AE, AR,AT, AU, BD, BE, BG, BO, BR, CA, CH, CL, CN, CO, CZ, DE, DK, DZ, ;EC EE, EG, ES, FI, FR, GB, GE, GF, GR, GT, HK, HR, HU, IE, IL, IN, IT, JO, JP, KE, KR, KW, LB, LT, MA, ME, MK, MM, MQ, MT, MX, MY, NG, NL, NO, NP, OM, PA, PE, PF, PH, PK, PL, PR, PT, PY, QA, RE, RO, RS, RU, SA, SE, SG, SI, SK, TH, TN, TR, TW, UA, YT, ZA and ZW.

## Key facts

- **Recall number:** Z-0638-2024
- **Recalling firm:** Philips Respironics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-11-27
- **Report date:** 2024-01-10

- **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-0638-2024

## Citation

> AI Analytics. FDA recall Z-0638-2024. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-0638-2024. Source: US FDA. Licensed CC0.

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