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Type of Product Medical Device
TGA Recall Reference RC-2018-RN-00351-1
Product Name/Description FUJIFILM General X-ray System FDR Smart f series

ARTG Number: 197063
(Fujifilm Australia - X-ray system, diagnostic, general-purpose, stationary, analogue)
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 23/04/2018
Responsible Entity Fujifilm Australia Pty Ltd
Reason/Issue Fujifilm has identified that FDR Smart f systems should have been sold and installed with the stated condition of:

“operation in the shielded room over 20 dB Radiated Emission attenuation”.

The units have been sold with no such condition being stated.
Recall Action Product Defect Correction
Recall Action Instructions Fujifilm are advising service personnel will contact all of the medical facilities where the applicable products have been installed to arrange for this correction and visit to take corrective measures. Correction will include the addition of ferrite cores, cable shielding and replacement of internal hardware and a firmware update.

This action has been closed out on 09/07/2019

This action has been closed out on 09/07/2019
Contact Information 02 9466 2600 - Fujifilm