||February 09, 2011
||Fujinon Endoscope Series;
Model # EPX-4400 and EPX-4400HD.
Digital processing of images from endoscope.
10 Highpoint Dr
Wayne, New Jersey 07470
|For Additional Information Contact
||Ms. Gina Walljasper
|The FICE feature installed in video endoscopic processors is being disabled since this feature should have been reviewed under the premarket notification/510k process.
||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