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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:110039

0.7/1.3U163CS-36 In combination with below systems MobileArt Evolution, MobileDaRt Evolution Product Usage: The device is a mobile X-ray system in order to take general radiography of patients in the hospital who cannot move and/or of outpatients in emergency.

Official recall number

Z-0263-2013

Evidence summary

Product code
IZL
Recall status
Terminated
Event initiated
October 28, 2011
Root cause
Nonconforming Material/Component
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-0263-2013