13 results · 39ms · Sources: EU EUDAMED, US FDA

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Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: MXU-RV35 Product Description: Rover Mobile X-rays System ("Rover") is a mobile imaging system that incorporates a self-contained X-ray generator, imaging display and software for acquiring medical diagnostic images outside a standard X-ray room. It is designed specifically for Digital Radiography (DR) with vendor-supported detectors. The Rover is designed to perform radiographic X-ray examinations for disease/injury detection, diagnosis, medical and surgical treatment planning, and therapy monitoring, where patient condition contraindicates transport to a fixed X-ray unit The Rover can be used on pediatric and adult patients, in all patient treatment areas Component: N/A

FDA Recall
Open, Classified ·Micro-X Ltd. Unit 14 6 Mab Eastern Promenade Tonsley Australia·Product code IZL·March 28, 2025

Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: MXU-RV71 Product Description: Rover Mobile X-rays System ("Rover") is a mobile imaging system that incorporates a self-contained X-ray generator, imaging display and software for acquiring medical diagnostic images outside a standard X-ray room. It is designed specifically for Digital Radiography (DR) with vendor-supported detectors. The Rover is designed to perform radiographic X-ray examinations for disease/injury detection, diagnosis, medical and surgical treatment planning, and therapy monitoring, where patient condition contraindicates transport to a fixed X-ray unit The Rover can be used on pediatric and adult patients, in all patient treatment areas Component: N/A

FDA Recall
Open, Classified ·Micro-X Ltd. Unit 14 6 Mab Eastern Promenade Tonsley Australia·Product code IZL·March 28, 2025

Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number:MXU-RV35 Product Description: Rover Mobile X-rays System ("Rover") is a mobile imaging system that incorporates a self-contained X-ray generator, imaging display and software for acquiring medical diagnostic images outside a standard X-ray room. It is designed specifically for Digital Radiography (DR) with vendor-supported detectors. The Rover is designed to perform radiographic X-ray examinations for disease/injury detection, diagnosis, medical and surgical treatment planning, and therapy monitoring, where patient condition contraindicates transport to a fixed X-ray unit The Rover can be used on pediatric and adult patients, in all patient treatment areas Component: N/A

FDA Recall
Open, Classified ·Micro-X Ltd. Unit 14 6 Mab Eastern Promenade Tonsley Australia·Product code IZL·April 4, 2025

Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: MXU-RV71, MXU-RV35 Product Description: Rover Mobile X-rays System ("Rover") is a mobile imaging system that incorporates a self-contained X-ray generator, imaging display and software for acquiring medical diagnostic images outside a standard X-ray room. It is designed specifically for Digital Radiography (DR) with vendor-supported detectors. The Rover is designed to perform radiographic X-ray examinations for disease/injury detection, diagnosis, medical and surgical treatment planning, and therapy monitoring, where patient condition contraindicates transport to a fixed X-ray unit The Rover can be used on pediatric and adult patients, in all patient treatment areas Component: N/A

FDA Recall
Open, Classified ·Micro-X Ltd. Unit 14 6 Mab Eastern Promenade Tonsley Australia·Product code IZL·April 4, 2025

MICRO-X ROVER MOBILE X-RAY SYSTEM, MXU-RV19

FDA Recall
Open, Classified ·Micro-X Ltd. A14 6 MAB Eastern Promenade Tonsley Australia·Product code IZL·August 31, 2022

Rover Mobile X-ray System Model/Catalog Number: MXU-RV35 and MXU-RV71

FDA Recall
Open, Classified ·Micro-X Ltd. Unit 14 6 Mab Eastern Promenade Tonsley Australia·Product code IZL·March 27, 2026

MICRO-X Rover Mobile X-ray System, # MXU-RV35; MICRO-X Rover Mobile X-ray System, # MXU-RV71

FDA Recall
Open, Classified ·Micro-X Ltd. Unit 14 6 Mab Eastern Promenade Tonsley Australia·Product code IZL·November 28, 2023

MICRO-X Rover Mobile X-ray System, # MXU-RV35

FDA Recall
Open, Classified ·Micro-X Ltd. Unit 14 6 Mab Eastern Promenade Tonsley Australia·Product code IZL·May 31, 2023

MICRO-X Rover Mobile X-ray System, # MXU-RV35

FDA Recall
Open, Classified ·Micro-X Ltd. Unit 14 6 Mab Eastern Promenade Tonsley Australia·Product code IZL·October 22, 2024

MICRO-X Rover Mobile X-ray System, # MXU-RV19

FDA Recall
Open, Classified ·Micro-X Ltd. Unit 14 6 Mab Eastern Promenade Tonsley Australia·Product code IZL·October 23, 2024

Trident Endoscopic Ultrasonic Biopsy Needle (FNB)

FDA Recall
Terminated ·Micro-Tech (Nanjing) Co., Ltd. High Tech NO. 10 Gaoke Third Road Nanjing National Nanjing China·Product code ODG·March 12, 2018

Trident Endoscopic Ultrasonic Aspiration Needle (FNA)

FDA Recall
Terminated ·Micro-Tech (Nanjing) Co., Ltd. High Tech NO. 10 Gaoke Third Road Nanjing National Nanjing China·Product code ODG·March 12, 2018

Single-Use Biopsy Forceps, JUMBO ALLIGATOR,3.2mm, REF Catalog No. NBF13-01130230, UPN BF40180 (Pouch level) - BF40181(Case box level) BF40182 (Carton box level) - BF40183(Over shipper level), STERILE

FDA Recall
Terminated ·Micro-Tech (Nanjing) Co., Ltd. High Tech NO. 10 Gaoke Third Road Nanjing National Nanjing China·Product code GEN·September 20, 2018