Philips Respironics Recalls Trilogy EVO Ventilators Due to Software Alarm Defect
Philips Respironics is recalling five Trilogy EVO Ventilators because a software defect causes the loss of all power alarms.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a defect that disables safety alarms, creating a risk of harm to patients, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Philips Respironics, Inc. is recalling five units of the Trilogy EVO Ventilator (Model Number: FR2110X14B) due to a software defect. The affected units are running software versions 1.00.05, 1.01.09.00, 1.01.10.00, or 1.01.11.00.
The defect causes the ventilator's power alarms to become inoperative, resulting in a loss of all power alarms. This failure means the device may not alert users to power issues, which fails specific safety requirements (TSRS1298 and PRD439) and can lead to incorrect or unexpected results.
The recall affects five specific units distributed outside the United States in countries including France, Germany, Denmark, Italy, Ireland, the United Kingdom, Kuwait, Qatar, Poland, Spain, Austria, the Philippines, the United Arab Emirates, Slovenia, and the Czech Republic. No units were distributed in the US. Affected serial numbers include H248213027F13, H249718745CF4, H252330869C7A, H252331053AFD, and H255249974881. Users should contact the recalling firm for instructions on how to address the software defect.
The recalled product
- Product
- Trilogy EVO Ventilator, France - Model Number: FR2110X14B 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 acc
- Manufacturer
- Philips Respironics, Inc.
- Category
- Medical Device — Ventilator
- Affected units
- 5
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Model/Material Number: FR2110X14B Serial Numbers: H248213027F13
- H249718745CF4
- H252330869C7A
- H252331053AFD
- H255249974881
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 13 recalled by Philips Respironics, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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