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

FDA device recall Z-1067-2011 · posted 2011-02-09 · Terminated

Recall details

Recalling firm

Fujinon Inc

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 taken

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.

Root cause

PMA

Status

Terminated

Quantity affected

783 units

Distribution

Nationwide Distribution

Date initiated

2011-01-07

Date posted

2011-02-09

Date terminated

2012-06-04

Location

Wayne, NJ