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 1 Device Recall Trilogy Evo Universal Ventilator

  • 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 1 Device Recall Trilogy Evo Universal Ventilator see related information
Date Initiated by Firm March 19, 2024
Date Posted April 17, 2024
Recall Status1 Open3, Classified
Recall Number Z-1505-2024
Recall Event ID 94263
510(K)Number K181170  
Product Classification Ventilator, continuous, facility use - Product Code CBK
Product Trilogy Evo Universal Ventilator, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients.
Code Information Model No. DS2000X11B; UDI-DI: 606959052000; All units except those with software version 1.05.06.00.
Recalling Firm/
Manufacturer		 Philips Respironics, Inc.
1001 Murry Ridge Ln
Murrysville PA 15668-8517
For Additional Information Contact Philips Customer Service
1-800-345-6443
Manufacturer Reason
for Recall		 Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power.
FDA Determined
Cause 2		 Device Design
Action Consignees were mailed an URGENT MEDICAL DEVICE CORRECTION notice, dated 3/7/24. Consignees are asked to identify any affected product in their inventory and follow the provided instructions in order to continue using devices safely in CPAP or PSV mode. Devices that alarm are to be immediately plugged into a power source if a Loss of Power Alarm occurs. If no source of power is available, remove and replace the detachable battery. Devices running on software other than 1.05.06.00 can be updated to the latest software version, which does not experience this failure mode. The provided recall notice should be shared with all members of consignee organizations that utilize the recalled devices. If product was further distributed the provided notice should be forwarded. Consignees with any questions can contact Philips Respironics Customer Service at 1-800-345-6443 for homecare customers or 1-800-722-9377 for hospital customers.
Quantity in Commerce 9,999 units
Distribution Domestic: Nationwide Distribution; Foreign: AE, AR, AT, AU, BD, BE, BG, BO, BR, BS, CA, CH, CL, CN, CO, CZ, DE, DK, DZ, EC, EE, EG, ES, FI, FR, GB, GE, GF, GI, GR, GT, HK, HR, HU, ID, IE, IL, IN, IT, JE, JO, JP, KE, KR, KW, LB, LT, MA, ME, MK, MM, MQ, MT, MX, MY, NG, NL, NO, NP, NZ, 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, US, UY, VN, YT, ZA, 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.
-
-