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  1. FDA Recalls
  2. ›Device Recalls

FDA Device Recalls

Recalls of medical devices, diagnostic equipment, implants, and surgical instruments.

Classification
AllClass IClass IIClass III
Status
AllOngoingCompletedTerminated
Date
All timePast 30 daysPast 12 months

Showing 301–320 of 1,000 recalls

Class ITerminated

0.035"(.89mm)x80 cm guidewire. Model 114135080. Soft Tip 3.5cm. REF/UDI: 114135080/(01)208863333008067. RxOnly STERILE EO

Argon Medical Devices, Inc

The stiffness of the soft end of the guidewire caused tissue perforation.

December 4, 2019 · DeviceView details →
Class ITerminated

Carestation 620/650/650c A2 Product Usage: anesthesia systems are intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (pediatric and adult.

GE Healthcare, LLC

GE Healthcare has become aware that there is a potential for a loose cable connection inside specific manufactured anesthesia devices. This would cause a loss of mechanical ventilation and the system will provide high priority audio and visual alarms. Loss of mechanical ventilation could lead to hypoxia if the clinician does not intervene.

November 25, 2019 · Device
View details →
Class ITerminated

Carestation 620/650/650c A1 Product Usage: anesthesia systems are intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (pediatric and adult.

GE Healthcare, LLC

GE Healthcare has become aware that there is a potential for a loose cable connection inside specific manufactured anesthesia devices. This would cause a loss of mechanical ventilation and the system will provide high priority audio and visual alarms. Loss of mechanical ventilation could lead to hypoxia if the clinician does not intervene.

November 25, 2019 · DeviceView details →
Class ITerminated

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 accessories.

Philips Respironics, Inc.

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.

November 19, 2019 · DeviceView details →
Class ITerminated

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 accessories.

Philips Respironics, Inc.

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.

November 19, 2019 · DeviceView details →
Class ITerminated

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 accessories.

Philips Respironics, Inc.

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.

November 19, 2019 · DeviceView details →
Class ITerminated

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 accessories.

Philips Respironics, Inc.

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.

November 19, 2019 · DeviceView details →
Class ITerminated

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 accessories.

Philips Respironics, Inc.

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.

November 19, 2019 · DeviceView details →
Class ITerminated

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 accessories.

Philips Respironics, Inc.

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.

November 19, 2019 · DeviceView details →
Class ITerminated

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 appropriate accessories.

Philips Respironics, Inc.

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.

November 19, 2019 · DeviceView details →
Class ITerminated

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 accessories.

Philips Respironics, Inc.

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.

November 19, 2019 · DeviceView details →
Class ITerminated

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 accessories.

Philips Respironics, Inc.

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.

November 19, 2019 · DeviceView details →
Class ITerminated

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 appropriate accessories.

Philips Respironics, Inc.

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.

November 19, 2019 · DeviceView details →
Class ITerminated

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 appropriate accessories.

Philips Respironics, Inc.

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.

November 19, 2019 · DeviceView details →
Class ITerminated

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 appropriate accessories.

Philips Respironics, Inc.

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.

November 19, 2019 · DeviceView details →
Class ITerminated

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.

Philips Respironics, Inc.

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.

November 19, 2019 · DeviceView details →
Class ITerminated

PneumoDart, 14 ga x 3.25in., REF TM-317 A compact, sterile, device intended for the introduction into the body to facilitate the removal of air from the pleural cavity as a result of a tension pneumothorax condition.

Tytek Medical Inc

A defect involving an occluded needle was discovered during a training exercise.

November 15, 2019 · DeviceView details →
Class ITerminated

CrossCath Support Catheter, RPN CXC3.4-2.2-18-90-P-NS-0, Order Number G51575 For diagnostic and interventional vascular procedures.

Cook Inc.

A manufacturing error may cause the radiopaque marker bands to be too loose on certain CXC3.0 CrossCath Support Catheters (compatible with 0.014 wire guides) and too tight on certain CXC3.4 CrossCath Support Catheters (compatible with 0.018 wire guides).

November 8, 2019 · DeviceView details →
Class ITerminated

CrossCath Support Catheter, RPN CXC3.4-2.2-18-150-P-NS-0, Order Number G51577 For diagnostic and interventional vascular procedures.

Cook Inc.

A manufacturing error may cause the radiopaque marker bands to be too loose on certain CXC3.0 CrossCath Support Catheters (compatible with 0.014 wire guides) and too tight on certain CXC3.4 CrossCath Support Catheters (compatible with 0.018 wire guides).

November 8, 2019 · DeviceView details →
Class ITerminated

CrossCath Support Catheter, RPN CXC3.4-2.2-18-135-P-NS-0, Order Number G51583 For diagnostic and interventional vascular procedures.

Cook Inc.

A manufacturing error may cause the radiopaque marker bands to be too loose on certain CXC3.0 CrossCath Support Catheters (compatible with 0.014 wire guides) and too tight on certain CXC3.4 CrossCath Support Catheters (compatible with 0.018 wire guides).

November 8, 2019 · DeviceView details →
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