Trilogy EVO Ventilator recall: Software Issue
Trilogy EVO Ventilator, 02 - Italy - Model Number: IT2100X21B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg.…
Why was Trilogy EVO Ventilator recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model/Material Number: IT2100X21B Serial Numbers: H24371481043C, H243714900C6D, H24371504C78D,
- Product
- Trilogy EVO Ventilator, 02 - Italy - Model Number: IT2100X21B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg.…
- Recalling firm
- Philips Respironics, Inc.
- Quantity
- 3
- Distribution
- US: None OUS: CH DE DK IT FR IE GB KW QA PL ES AT PH AE SI CZ
- Recall date
- February 26, 2020
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (device)