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Sources: EU EUDAMED, US FDA
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FDA Recall
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Overhead Counterpoise Systems (OCS), OCS CONF,STD CEIL MNT, STD HORZ ARM, Catalog # OCS 115A, Material Number 59880253
FDA Recall
Terminated
·Bayer Medical Care, Inc.·Product code JAK·June 28, 2018
Overhead Counterpoise Systems (OCS) OCS CONF an accessory device for use with Bayer injector systems as a support for an injector head. , SHORT CEIL MNT, STD HORZ ARM, Catalog # OCS 115AS, Material Number 59880288
FDA Recall
Terminated
·Bayer Medical Care, Inc.·Product code JAK·June 28, 2018
Puritan Bennett KnightStar 330 Bi-Level Ventilator, Catalogue Numbers: Y-KS330-NA, Y-KS330-SD, DSY-KS330-NA, DSY-K5330-SD, DLY-KS330-NA & DLY-KS330-SD
FDA Recall
Terminated
·Puritan Bennett Corporation·Product code MNT·August 31, 2006
BiPAP A40 Ventilators: BiPAP A40, Part Numbers 1111169 (US and OUS) and (OUS ONLY)1111170 1111171 1111173 1111174 1111175 1111177 1116156 1111170S BR1111169 CN1111169 IT1111169 R1111169 R1111177 R1116156 ; BiPAP A40 Pro, Part Numbers (OUS Only): ARX3100S19 AUX3100S19 BLX3100S19 BRX3100S18 CAX3100S12 CAX3100T12 DEX3100S13 EEX3100S19 ESX3100S19 FRX3100S14 GBX3100H19 GBX3100S19 IAX3100S19 INX3100H19 INX3100S19 ITX3100S21 SPX3100S19 ; BiPAP A40 EFL, Part Numbers (OUS Only): AUX3000S19 DEX2900S13 DEX3000S13 EEX3000S19 ESX3000S19 FRX3000S14 GBX3000S19 INX3000H19 ITX3000S21
FDA Recall
Open, Classified
·Philips Respironics, Inc.·Product code MNT·March 26, 2024
BiPAP A40, China: Continuous ventilator, non-life-supporting. Material Number - CN1111169
FDA Recall
Terminated
·Philips Respironics, Inc.·Product code MNT·April 6, 2021
Philips Respironics V60 Plus Ventilator with Software Versions 3.00 and 3.10. The Respironics V60/V60 Plus Ventilator is an assist ventilator and is intended to augment patient breathing. It is intended for spontaneously breathing individuals who require mechanical ventilation: patients with respiratory failure, chronic respiratory insufficiency, or obstructive sleep apnea in a hospital or other institutional settings under the direction of a physician.
FDA Recall
Open, Classified
·Respironics California, LLC·Product code MNT·June 18, 2021
Philips Respironics V60 Ventilator Part Number 1076717 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
FDA Recall
Terminated
·Respironics California, LLC·Product code MNT·October 30, 2020
Philips Respironics V60 Plus Ventilator Part Number 1138747 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
FDA Recall
Terminated
·Respironics California, LLC·Product code MNT·October 30, 2020
Philips Respironics V60 Ventilator Part Number U1053617 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
FDA Recall
Terminated
·Respironics California, LLC·Product code MNT·October 30, 2020
Philips Respironics V60 Plus Ventilator Part Number 1138747
FDA Recall
Open, Classified
·Respironics California, LLC·Product code MNT·January 24, 2022
BiPAP A40 Ventilator. Used to provide noninvasive ventilation support for the purpose of treating adult and pediatric patients. BiPAP A40 Pro - sold OUS
FDA Recall
Open, Classified
·Philips Respironics, Inc.·Product code MNT·May 9, 2025
Philips Respironics V60 Plus Ventilator Part Number 1138747 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
FDA Recall
Open, Classified
·Respironics California, LLC·Product code MNT·November 2, 2020
Philips Respironics V60 Ventilator Part Number 1076709 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
FDA Recall
Open, Classified
·Respironics California, LLC·Product code MNT·November 2, 2020
Philips Respironics V60 Ventilator Part Number 1053617 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
FDA Recall
Open, Classified
·Respironics California, LLC·Product code MNT·November 2, 2020
Philips Respironics V60 Ventilator Part Number R1076709 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
FDA Recall
Open, Classified
·Respironics California, LLC·Product code MNT·November 2, 2020
Philips Respironics V60 Plus Ventilator Part Number 1137276 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
FDA Recall
Terminated
·Respironics California, LLC·Product code MNT·October 30, 2020
Philips Respironics V60 Ventilator Part Number 1053618 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
FDA Recall
Open, Classified
·Respironics California, LLC·Product code MNT·November 2, 2020
Philips Respironics V60 Ventilator Part Number DU1053617 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
FDA Recall
Terminated
·Respironics California, LLC·Product code MNT·October 30, 2020
Philips Respironics V60 Ventilator Part Number 1053614 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
FDA Recall
Terminated
·Respironics California, LLC·Product code MNT·October 30, 2020
MVP-10 Pediatric/ Neonatal Volume Ventilator
FDA Recall
Terminated
·Bio-Med Devices, Inc.·Product code MNT·November 7, 2003