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U.S. Department of Health and Human Services

Medical Device Recalls

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  Medical Device Recalls see related information
Date Initiated by Firm January 07, 2011
Create Date February 09, 2011
Recall Status1 Terminated 3
Recall Number Z-1067-2011
Recall Event ID 57676
Product Fujinon Endoscope Series;
Model # EPX-4400 and EPX-4400HD.

Digital processing of images from endoscope.
Recalling Firm/
Fujinon Inc
10 Highpoint Dr
Wayne NJ 07470
For Additional Information Contact Ms. Gina Walljasper
Manufacturer Reason
for Recall
The FICE feature installed in video endoscopic processors is being disabled since this feature should have been reviewed under the premarket notification/510k process.
Action Fujinon sent an Urgent Medical Device Corrective Action Letter, dated 1/7/2011, via overnight mail to all consignees. The letter advises users that the FICE feature should no longer be used and that a Fujinon Field Service Engineer will be coming to physically disable the FICE feature on the processor. Instructions labeled as Attachment B are provided to assist in ceasing use of the FICE function. Attachment A is provided for frequently asked questions. Customers are to complete the Response/Acknowledgement Form and either fax it or email back to the firm. If there are additional questions, customers can call 800-385-4666 or email products.fice.@fujinon.com.
Quantity in Commerce 783 units
Distribution Nationwide Distribution

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.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.