57 results
·
78ms
·
Sources: EU EUDAMED, US FDA
ICON 9.5 Software used on the ICON workstations designed for use with the E.CAM Emission Imaging Computed Tomography Systems; Siemens Medical Systems, Inc., Nuclear Medicine Group, Hoffman Estates, IL 60195-5203
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc.·Product code JWM·February 10, 2003
DA VINCI S
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL, INC·Product code NAY·March 11, 2019
PCR Eleva Radiological Image Processing System with software R.1.2 Philips Healthcare, Inc. A computed radiography image processing system.
FDA Recall
Terminated
·Philips Healthcare Inc.·Product code LLZ·July 27, 2011
O-ARM 1000 IMAGING SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC. (LITTLETON)·Product code OXO·August 2, 2016
O-ARM 1000 IMAGING SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC. (LITTLETON)·Product code OXO·August 4, 2016
O-ARM 1000 IMAGING SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC. (LITTLETON)·Product code OXO·October 31, 2016
O-ARM O2 IMAGING SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC. (LITTLETON)·Product code OWB·December 1, 2016
DAVINCI 5
FDA Adverse Event
Injury
·INTUITIVE SURGICAL, INC·Product code NAY·December 29, 2025
INTERSTIM II
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·August 4, 2014
DAVINCI XI
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL, INC·Product code NAY·June 24, 2022
GUARDIAN LINK 3 US
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OZP·August 17, 2023
UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code DHA·October 14, 2011
MEDRAD ANGIOGRAPHIC/CT INJECTOR
FDA Adverse Event
Injury
·BAYER MEDICAL CARE INC·Product code DXT·March 12, 2025
CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ MEDIUM
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER INC·Product code DYB·April 17, 2024
THMCL SMTCH SF BID, TC, D-F
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER INC·Product code LPB·July 11, 2024
DAVINCI XI
FDA Adverse Event
Injury
·INTUITIVE SURGICAL, INC·Product code NAY·June 28, 2022
SMARTPHONE ANDROID APP: PUMP CONNECT
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code PKU·November 4, 2022
SMARTPHONE ANDROID APP: PUMP CONNECT
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code PKU·January 10, 2024
GUARDIAN LINK 3 OUS
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OZP·July 6, 2023
GUARDIAN LINK 3 US
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OZP·August 29, 2023