Class 2 Device Recall Smart CR Digital Computed Radiography System

• Date Initiated by Firm: April 01, 2016
• Create Date: May 03, 2016
• Recall Status: Terminated on July 11, 2018
• Recall Number: Z-1599-2016
• Recall Event ID: 73668
• 510(K)Number: K944046
• Product Classification: Processor, radiographic-film, automatic - Product Code IXW
• Product: Smart CR Digital Computed Radiography System; Model Number: CR-IR346RU
• Code Information: All serial numbers.
• Recalling Firm/ Manufacturer: Fujifilm Medical Systems U.S.A., Inc.; 419 West Ave; Stamford CT 06902-6343
• For Additional Information Contact: 888-385-4633 Ext. 2
• Manufacturer Reason for Recall: Reports of failure of the device's power supply.
• FDA Determined Cause: Device Design
• Action: Fujifilm sent an Medical Device Correction letter dated March 22, 2016, via FedEx to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Instructions for turning the unit off when not in use as an interim action. FMSU will conduct a field replacement of the power supply in all installed units. For further questions, please call (888) 385-4633.
• Quantity in Commerce: 2,062 devices
• Distribution: Nationwide Distribution.
• 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 = IXW and Original Applicant = FUJIFILM MEDICAL SYSTEM U.S.A., INC.