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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm September 30, 2004
Date Posted October 28, 2004
Recall Status1 Terminated 3 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 2		 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 and Original Applicant = FUJIFILM MEDICAL SYSTEM U.S.A., INC.
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