Class 2 Device Recall Fujifilm Aspire HD, Full Field Digital, System

• Date Initiated by Firm: February 03, 2015
• Date Posted: May 06, 2015
• Recall Status: Terminated on May 20, 2015
• Recall Number: Z-1585-2015
• Recall Event ID: 70854
• 510(K)Number: K110729
• Product Classification: Full field digital,system,x-ray,mammographic - Product Code MUE
• Product: Aspire HD, Full Field Digital, System, x-Ray, Mammographic;; Model: FOR MS-1000.; ; A mammography system used for screening and diagnosis of breast cancer.
• Code Information: Serial Number: 26320119
• Recalling Firm/ Manufacturer: Fujifilm Medical Systems U.S.A., Inc.; 419 West Ave; Stamford CT 06902-6343
• For Additional Information Contact: 203-324-2000
• Manufacturer Reason for Recall: User Manual lacks a description for handling some errors even though the system can be recovered from such errors
• FDA Determined Cause: Labeling Change Control
• Action: Fuji Film on 2/3/15, issued a User Notification letter and the recovery procedure were hand carried to the user. A copy of Notification Letter is user's acknowledgement of receipt of the manual .
• Quantity in Commerce: 1 unit
• Distribution: Distributed in HI.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = MUE and Original Applicant = FUJIFILM MEDICAL SYSTEMS, USA INC.