| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00961-1 |
| Product Name/Description |
Fujifilm MS Swivel Arm
Serial Numbers:
MS-3500 (76221095 or earlier)
MS-2500 (Made in Japan - 16640001 or later)
MS-2500 (Made in China - 26860001 or later)
MS-2000 (Made in Japan - 16650001 or later)
MS-2000 (Made in China - 26870001 or later)
ARTG: 159785 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
8/08/2017 |
| Responsible Entity |
|
| Reason/Issue |
FUJIFILM has become aware of a potential issue with the Fujifilm MS (Mammography System) swivel arm. It was found that in one case, the coupling key connecting the ball screw and the motor for moving the swivel arm up/down of the FDR MS-3500 was removed, causing the swivel arm to move downwards.
Whilst the probability of this occurring is considered to be very low, FUJIFILM wishes to reduce any potential risk to patients by undertaking this action. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Fujifilm is requesting that:
1. Once a Fujifilm engineer has checked and tightened the coupling key, users will need to complete the Customer Feedback form supplied with the original Customer Letter and return it by post, fax or email as per the instructions given.
This action has been closed out on 11/07/2019 |
| Contact Information |
02 9466 2600 - Fujifilm |