Trilogy EVO Ventilator, 02 - International - Model Number: IN2100X15B Trilogy Evo is intended for pediatric through adul

FDA device recall Z-0950-2020 · posted 2020-02-15 · Terminated

Recall details

Recalling firm

Philips Respironics, Inc.

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.

Action taken

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

Root cause

Software design

Status

Terminated

Product code

CBK

Quantity affected

21

Distribution

US: None OUS: CH DE DK IT FR IE GB KW QA PL ES AT PH AE SI CZ

Date initiated

2019-11-19

Date posted

2020-02-15

Date terminated

2021-03-31

Location

Murrysville, PA

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