FIELD SAFTY NOTICE
Contents
1. Error Occurs During a Biopsy Study Actions to be taken by customer user Read the simplified manual When performing a biopsy keep the simplified manual handy to lower the risk of re examination If any of the following errors occurs perform the correction procedure in the manual 1 Error of the exposure system Page 2 and following pages in the manual 2 Error of the biopsy positioner Page 8 and following pages in the manual 3 Error of the Stereo Biopsy Software Page 14 and following pages in the manual Although the probability of the above errors is very rare performing the operation according to the manual will lower the risk of requiring re examination in case such errors occur FUJIFILM is committed to providing products and services of the highest quality Your satisfaction with FUJIFILM products and with our response to this issue is very important to us If you have any questions about this matter please contact your local FUJIFILM office Yours sincerely FUJIFILM FUJIFILM Field Safety Notice Reference FSN 20141212 AMULET FIELD SAFTY NOTICE Customer Feedback Form Please complete the feedback form as relevant and fax or email it back Thank you for your co operation Customer Facility Name Address Instrument Serial Number _ I confirm that have received and understand the attached notice L_ This notice does not apply to my facility L The device has been transferred to another organization Custome2. FUJIFILM Field Safety Notice Reference FSN 20141212 AMULET FIELD SAFTY NOTICE Product FUJIFILM Digital Mammography System with Biopsy unit AMULET FDR MS 1000 AMULET f FDR MS 2500 AMULET Innovality FDR MS 3500 Type of Action Advice regarding use of the device Dear Customers Fujifilm is issuing this Field Safety Notice for all AMULETs with biopsy unit This Field Safety Notice is intended to inform you about the following e what the problem is e the actions that should be taken by the customer user in order to prevent risks to patients This document contains important information for the continued safe and proper use of your equipment Please review the following information with all members of your staff who need to be aware of the contents of this communication It is important to understand the implications of this communication Description of the problem During a biopsy study using the FUJIFILM Digital Mammography System it has been found that the User Manual lacks description for handling method for some errors even though the system can be recovered from such errors If users do not address the recovery procedure properly there may be an undeniable possibility that the examination is suspended leading to patient re examination Thus the simplified manual describing the recovery procedure has been created to be distributed to the users who perform a biopsy study Simplified manual Action to Take When an
3. r Name Position Signature Date Phone number If we have the wrong contact information for you please correct below Customer Facility Name Address Please FAX or email this completed form to
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