FDA (Devices) recall action 84406

Philips Respironics, Inc. recalled 13 products on 2020-02-26

The FDA (Devices) publishes a recall like this one as 13 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 13 pages.

Products: 13
Announced: 2020-02-26
Critical: 4
Units: 330

Why these products were 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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–13 of 13

HighFDA (Devices)··2020-02-26
Philips Respironics Recalls Trilogy EVO Ventilators Due to Software Defect
Philips Respironics is recalling 16 Trilogy EVO ventilators because a software defect causes power alarms to become inoperative or lost.
Product
Trilogy EVO Ventilator, Nordics - Model Number: ND2110X15B 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 ac
Category
Distribution
0 states
HighFDA (Devices)··2020-02-26
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.
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
Category
Distribution
0 states
HighFDA (Devices)··2020-02-26
Philips Respironics Recalls Trilogy EVO Ventilators Due to Software Defect
Philips Respironics is recalling eight Trilogy EVO Ventilators because a software defect causes the loss of all power alarms.
Product
Trilogy EVO Ventilator, Iberia - Model Number: ES2110X15B 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
Category
Distribution
0 states
SevereFDA (Devices)··2020-02-26
Philips Respironics Recalls Trilogy EVO Ventilators Due to Software Defect
Philips Respironics is recalling 27 Trilogy EVO ventilators because a software defect causes the loss of all power alarms.
Product
Trilogy EVO Ventilator, 02 - EU - Model Number: EU2100X15B 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 ac
Category
Distribution
0 states
SevereFDA (Devices)··2020-02-26
Philips Respironics Recalls Trilogy EVO Ventilators Due to Software Defect
Philips Respironics is recalling 48 Trilogy EVO ventilators due to a software defect that causes inoperative power alarms. The units were distributed in 15 countries outside the US.
Product
Trilogy EVO Ventilator, EU - Model Number: EU2110X15B 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 accesso
Category
Distribution
0 states
SevereFDA (Devices)··2020-02-26
Philips Respironics Recalls Trilogy EVO Ventilators Due to Software Defect
Philips Respironics is recalling 105 Trilogy EVO ventilators because a software defect causes inoperative power alarms. The units are distributed internationally but not in the US.
Product
Garbin EVO Ventilator, Linde - Model Number: LD2110X23B 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 acces
Category
Distribution
0 states
CriticalFDA (Devices)··2020-02-26
Philips Respironics Recalls Trilogy EVO Ventilators Due to Software Defect
Philips Respironics is recalling 21 Trilogy EVO Ventilators because a software defect causes the loss of all power alarms.
Product
Trilogy EVO Ventilator, 02 - International - Model Number: IN2100X15B 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 app
Category
Distribution
0 states
CriticalFDA (Devices)··2020-02-26
Philips Respironics Recalls Trilogy EVO Ventilators Due to Software Alarm Defect
Philips Respironics is recalling 15 Trilogy EVO Ventilators because a software defect causes the loss of all power alarms.
Product
Trilogy EVO Ventilator, Great Britain - Model Number: GB2110X15B 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 appropri
Category
Distribution
0 states
CriticalFDA (Devices)··2020-02-26
Philips Respironics Recalls Trilogy EVO Ventilators Due to Software Defect
Philips Respironics is recalling specific Trilogy EVO ventilators because a software defect causes power alarms to fail, potentially leaving patients without critical alerts.
Product
Trilogy EVO Ventilator, 02 - Iberia - Model Number: ES2100X15B 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 appropriat
Category
Distribution
0 states
SevereFDA (Devices)··2020-02-26
Philips Respironics Recalls Trilogy EVO Ventilators Due to Software Alarm Defect
Philips Respironics is recalling 31 Trilogy EVO Ventilators due to a software defect that causes the loss of all power alarms.
Product
Trilogy EVO Ventilator, Germany - Model Number: DE2110X13B 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 ac
Category
Distribution
0 states
CriticalFDA (Devices)··2020-02-26
Philips Respironics Recalls Trilogy EVO Ventilators Due to Software Alarm Defect
Philips Respironics is recalling 21 Trilogy EVO Ventilators because a software defect causes the loss of all power alarms.
Product
Trilogy EVO Ventilator, International, Model Number IN2110X15B 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 appropriat
Category
Distribution
0 states
SevereFDA (Devices)··2020-02-26
Philips Respironics Recalls Trilogy EVO Ventilators Due to Software Defect
Philips Respironics is recalling three Trilogy EVO Ventilators in Italy because a software defect causes the loss of all power alarms.
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
Category
Distribution
0 states
HighFDA (Devices)··2020-02-26
Philips Respironics Recalls LifeVent EVO Ventilators Due to Software Alarm Defect
Philips Respironics is recalling 29 LifeVent EVO ventilators because a software defect causes the loss of all power alarms.
Product
LifeVent EVO Ventilator, 02 - Model Number: SP2100X26B 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 access
Category
Distribution
0 states