Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Trilogy Evo and Trilogy Evo O2

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Trilogy Evo and Trilogy Evo O2 see related information
Date Initiated by Firm November 27, 2023
Date Posted January 04, 2024
Recall Status1 Open3, Classified
Recall Number Z-0638-2024
Recall Event ID 93609
510(K)Number K181166  
Product Classification Ventilator, continuous, facility use - Product Code CBK
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
Code Information 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.
Recalling Firm/
Manufacturer		 Philips Respironics, Inc.
1001 Murry Ridge Ln
Murrysville PA 15668-8517
For Additional Information Contact Philips Customer Service
800-345-6443
Manufacturer 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.
FDA Determined
Cause 2		 Device Design
Action On November 27, 2023, the firm sent "URGENT Medical Device Correction" letters to dated November 20, 2023, affected customers along with an attached manual addendum for insertion into current manuals. Customers were instructed to keep a copy of the letter and attached addendum with their Trilogy Evo or Trilogy Evo O2 Ventilator IFUs. Distributors were instructed to notify any customers to whom they have distributed affected devices. If you need any further information or support concerning this issue, please contact your local Philips representative: Call 1-(877)-387-3311 or email at patientsupport@philips.com
Quantity in Commerce 100,126 (54,691 US; 45,435 OUS) in total
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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = CBK and Original Applicant = Respironics Inc.
-
-