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U.S. Department of Health and Human Services

Class 1 Device Recall Trilogy EVO

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  Class 1 Device Recall Trilogy EVO see related information
Date Initiated by Firm November 19, 2019
Create Date February 15, 2020
Recall Status1 Open3, Classified
Recall Number Z-0951-2020
Recall Event ID 84406
510(K)Number K181166  
Product Classification Ventilator, continuous, facility use - Product Code CBK
Product Trilogy EVO Ventilator, 02 - Italy - Model Number: IT2100X21B

Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and Pulse Rate data when integrated with the appropriate accessories.
Code Information Model/Material Number: IT2100X21B Serial Numbers: H24371481043C, H243714900C6D, H24371504C78D,
Recalling Firm/
Manufacturer
Philips Respironics, Inc.
1001 Murry Ridge Ln
Murrysville PA 15668-8517
For Additional Information Contact Adam Price
412-542-3730
Manufacturer Reason
for Recall
Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW 1.01.09.00, SW 1.01.10.00, and SW 1.01.11.00, causing inoperative and loss of all power alarms. This defect causes an incorrect or unexpected result failing requirements TSRS1298 and PRD439.
FDA Determined
Cause 2
Software design
Action On November 19, 2019 the firm distributed Urgent Medical Device Recall Communication letters by mail stating: URGENT - Field Safety Notice Trilogy Evo, Garbin Evo, LifeVent Evo 2 Released Software Versions SW 1.00.05, SW 1.01.09.00, SW 1.01.10.00, and SW 1.01.11.00 Dear Customer, During engineering testing, Philips became aware of two (2) unlikely scenarios that result in the Trilogy Evo failing to alarm immediately and persistently after a loss of therapy event. The failure to alarm as designed is the result of the software on impacted Trilogy Evo devices not reacting properly to these events. Patients may be at risk should this problem occur while the patient is not being actively monitored. There have been no reports of harm or injury associated with this issue. Affected devices can continue to be used in accordance with this Field Safety Notice. This Field Safety Notice informs you of the following: " Description of the issue and the circumstances under which it can occur " Customer/user actions that are required to prevent risks for patients " Philips Respironics actions to resolve the issue This document contains important information for the continued safe and proper use of your equipment Please review the following information with all members of your staff who need to be aware of the contents of this communication. It is important to understand the implications of this communication. Please retain a copy with the equipment Instruction for Use. Should you have any questions or need further information regarding this communication, please do not hesitate to contact us at 1-724-387-4000 for all international calls. This notice has been reported to the appropriate regulatory agencies. We appreciate your support in reacting to this Field Safety Notice and sincerely regret any inconvenience that this action may cause you. HOW TO IDENTIFY AFFECTED PRODUCTS Affected models include Trilogy Evo, Garbin Evo, LifeVent Evo 2 units with s
Quantity in Commerce 3
Distribution US: None OUS: CH DE DK IT FR IE GB KW QA PL ES AT PH AE SI CZ
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.
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