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U.S. Department of Health and Human Services

Medical Device Recalls

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 Medical Device Recallssee related information
Recall Status1 Terminated
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/
Manufacturer
Fujinon Inc
10 Highpoint Dr
Wayne NJ 07470
For Additional Information Contact Ms. Gina Walljasper
973-686-2636
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
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