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Terminated

Fujinon Endoscope Series; Model # EPX-4400 and EPX-4400HD. Digital processing of images from endoscope.

FDA Recall Z-1067-2011 · Posted 2011-02-09

Recalling FirmFujinon Inc
Recall StatusTerminated
Date Initiated2011-01-07
Date Terminated2012-06-04
Product Quantity783 units

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.

Firm 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 [email protected].

Root Cause

PMA

Distribution Pattern

Nationwide Distribution

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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