Class 2 Device Recall

• Date Initiated by Firm: September 30, 2004
• Date Posted: October 28, 2004
• Recall Status: Terminated on December 22, 2004
• Recall Number: Z-0055-05
• Recall Event ID: 30206
• 510(K)Number: K993861
• Product Classification: Solid State X-Ray Imager (Flat Panel/Digital Imager) - Product Code MQB
• Product: Genital Protector Shield used with Fuji Computed Radiography (FCR) system models 5501D and XU/D1. Model: GP344
• Code Information: All lots
• Recalling Firm/ Manufacturer: Fujifilm Medical System USA, Inc.; 419 West Ave; Stamford CT 06902-6300
• For Additional Information Contact: Frank Gianeli; 203-602-3774
• Manufacturer Reason for Recall: Genital Protector Shield used with Fuji Computed Radiography (FCR) system models 5501D and XU/D1. Model: GP344 may detach from the mounting block and fall during use.
• FDA Determined Cause: Other
• Action: Fuji are notifying users through Fuji service representatives who are hand delivering the notfication letter dated 9/30/04 and installing the mandatory hardware upgrade.
• Quantity in Commerce: 16
• Distribution: CO, CT, NY, MD, MI, MN, NV, UT
• 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 = MQB