Philips Respironics, Inc.: Trilogy Evo and Trilogy Evo O2 Material Numbers BL2110X15B BR2110X18B CA2110X12B DE2100X13B DE2110X13B DS2100X11B DS2110X11B EE2100X15B EE2110X15B ES2100X15B ES2110X15B EU21

Hazard

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.

Details from the source

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, Quantity: 100,126 (54,691 US; 45,435 OUS) in total Lot/code info: Material UDI-DI/GTIN BL2110X15B 606959055520 BR2110X18B 606959055476 CA2110X12B 606959052307 DE2100X13B 606959054103 DE2110X13B 606959054110 DS2100X11B 606959051997 DS2110X11B 606959051942 EE2100X15B 606959055698 EE2110X15B 606959055544 ES2100X15B 606959054097 ES2110X15B 606959054080 EU2100X15B 606959055674 EU2100X19 606959055681 EU2110X15B 606959054981 FR2100X14B 606959055643 FR2110X14B 606959055506 FX2100X15B 606959061019 GB2110X15B 606959054127 IA2100X15B 606959055636 IA2110X15B 606959055490 IN2100X15B 606959054059 IN2100X19 606959055575 IN2110X15B 606959051959 IT2100X21B 606959055438 IT2110X21B 606959055421 JP2100X16B 606959055582 JP2110X16B 606959051973 KR2110X15B 606959055483 LA2100X15B 606959055599 LA2110X15B 606959055452 ND2110X15B 606959055513 RDE2100X13B RDE2110X13B RDS2110X11B 606959060517 RIN2100X15B RIN2110X15B RJP2100X16B RJP2110X16B UDS2110X11B 606959060500 All units of listed models are affected by this correction.

UPC codes

606959055520, 606959055476, 606959052307, 606959054103, 606959054110, 606959051997, 606959051942, 606959055698, 606959055544, 606959054097, 606959054080, 606959055674, 606959055681, 606959054981, 606959055643, 606959055506, 606959061019, 606959054127, 606959055636, 606959055490, 606959054059, 606959055575, 606959051959, 606959055438, 606959055421, 606959055582, 606959051973, 606959055483, 606959055599, 606959055452, 606959055513, 606959060517, 606959060500

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.