16 results
·
85ms
·
Sources: EU EUDAMED, US FDA
RESIUS 190 XPRES
FDA Adverse Event
Malfunction
·KONICA-MINOLTA MEDICAL IMAGING USA, INC.·Product code IWZ·October 13, 2009
Konica Minolta PrintLink III Model - ID/IV, code no. 0770, 0771 Medical Imaging Communication Device Model IV - product code 5000230 Model ID, product code 5000330 Konica Minolta Medical & Graphic, Inc. No. 26-2, Nishishinjuku 1-chrome, Shinjuku-ku, Tokoyo 163-0512, Japan
FDA Recall
Terminated
·Konica Minolta Medical Imaging USA, Inc.·Product code LMD·October 6, 2006
Regius Model 370 Digital Radiography Konica Minolta
FDA Recall
Terminated
·Konica Minolta Medical Imaging USA, Inc.·Product code MQB·July 14, 2006
ImagePilot, Model No. D9MA
FDA Recall
Terminated
·Konica Minolta Medical Imaging USA, Inc.·Product code LLZ·May 9, 2018
Sonimage HS1 Ultrasound Kit AC adapter, Product Number: A7AP, UDI: 04560141940031
FDA Recall
Terminated
·Konica Minolta Medical Imaging USA, Inc.·Product code IYN·December 4, 2017
CS-7, Model No. A4C1
FDA Recall
Terminated
·Konica Minolta Medical Imaging USA, Inc.·Product code MQB·May 9, 2018
Sonimage HS1 Ultrasound Kit AC adapter, Product Number: 1. A9RP, UDI: 04560141945463; 2. AAEU, UDI: 04560141946385; 3. A9RR, UDI: 04560141945470
FDA Recall
Terminated
·Konica Minolta Medical Imaging USA, Inc.·Product code IYN·December 4, 2017
Sonimage HS1 Ultrasound Kit AC adapter, Product Number: A8AR, UDI: 04560141941588
FDA Recall
Terminated
·Konica Minolta Medical Imaging USA, Inc.·Product code IYN·December 4, 2017
REGIUS Image Manager (AKA REGIUS IM, RIM). Catalogue Number 5900554. Centralized CR Image Quality Control. Patient throughput optimization via offloaded processing from various CR readers. Technologist review and audit. Key processing for specialized exams, totally automated processing for hands off operation. Centralized workflow device for dispersed readers environments. HIS/RIS patient status updates. Demographic Correction.
FDA Recall
Terminated
·Konica Minolta Medical Imaging USA, Inc.·Product code LLZ·February 6, 2006
Sonimage HS1 Ultrasound Kit AC adapter, Product Number: A8WA, UDI: 04560141944534
FDA Recall
Terminated
·Konica Minolta Medical Imaging USA, Inc.·Product code IYN·December 4, 2017
ImagePilot, Model No. D9MA
FDA Enforcement
Class II
·Terminated·Konica Minolta Medical Imaging USA, Inc.·July 4, 2018
Sonimage HS1 Ultrasound Kit AC adapter, Product Number: A7AP, UDI: 04560141940031
FDA Enforcement
Class II
·Terminated·Konica Minolta Medical Imaging USA, Inc.·April 4, 2018
Sonimage HS1 Ultrasound Kit AC adapter, Product Number: A8AR, UDI: 04560141941588
FDA Enforcement
Class II
·Terminated·Konica Minolta Medical Imaging USA, Inc.·April 4, 2018
Sonimage HS1 Ultrasound Kit AC adapter, Product Number: A8WA, UDI: 04560141944534
FDA Enforcement
Class II
·Terminated·Konica Minolta Medical Imaging USA, Inc.·April 4, 2018
Sonimage HS1 Ultrasound Kit AC adapter, Product Number: 1. A9RP, UDI: 04560141945463; 2. AAEU, UDI: 04560141946385; 3. A9RR, UDI: 04560141945470
FDA Enforcement
Class II
·Terminated·Konica Minolta Medical Imaging USA, Inc.·April 4, 2018
CS-7, Model No. A4C1
FDA Enforcement
Class II
·Terminated·Konica Minolta Medical Imaging USA, Inc.·July 4, 2018