Device evidence

device-recall:cfres:184407

Shimadzu Mobile X-Ray System, MobileDaRt Evolution (MX8 Version), with adjustable handle option, Made in Japan - Product Usage: The device is intended to be used to take a film, CR or general radiography of patients in the hospital who cannot move and/or of outpatients in emergency.

Official recall number

Z-0534-2021

Evidence summary

Product code: IZL
Recall status: Open, Classified
Event initiated: November 09, 2020
Root cause: Device Design
Source snapshot: 5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product: Z-0534-2021