Recall Z-1067-2011
Fujinon Inc · initiated January 7, 2011
Product
Fujinon Endoscope Series; Model # EPX-4400 and EPX-4400HD. Digital processing of images from endoscope.
Codes / lots: EPX-4400 - Catalog Number 5600092 4V395A279 4V395A438 4V395A441 4V395A442 2V395A005 2V395A007 2V395A018 2V395A019 2V395A084 4V395A558 4V395A294 4V395A454 2V395A257 2V395A258 2V395A263 2V395A267 2V395A283 4V395A039 2V395A033 4V395A306 2V395A228 4V395A174 4V395A264 4V395A309 4V395A163 4V395A166 4V395A179 4V395A124 2V395A078 4V395A262 4V395A278 4V395A378 4V395A431 4V395A432 4V395A433 4V395A435 4V395A446 4V395A447 4V395A479 4V395A492 4V395A495 4V395A503 4V395A506 4V395A511 4V395A572 4V395A577 4V395A691 4V395A692 4V395A697 4V395A720 4V395A733 4V395A736 4V395A752 2V395A111 2V395A245 4V395A507 2V395A083 4V395A223 2V395A001 4V395A168 2V395A106 4V395A361 4V395A742 4V395A749 4V395A571 4V395A295 2V395A022 2V395A023 4V395A699 4V395A461 4V395A462 4V395A466 4V395A471 2V395A069 4V395A162 4V395A167 4V395A468 4V395A302 4V395A436 4V395A439 4V395A440 4V395A449 4V395A502 4V395A517 2V395A103 2V395A104 2V395A150 2V395A158 4V395A540 4V395A541 4V395A544 1V395A113 2V395A294 2V395A295 2V395A297 2V395A310 2V395A318 4V395A085 4V395A087 2V395A227 2V395A232 2V395A233 2V395A206 1V395A086 4V395A043 4V395A066 4V395A744 4V395A233 4V395A255 4V395A303 4V395A379 4V395A409 4V395A756 4V395A786 4V395A430 4V395A448…
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.
FDA-determined cause: PMA
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.
Details
- Recall number
- Z-1067-2011
- Initiated
- January 7, 2011
- Posted by FDA
- February 9, 2011
- Terminated
- June 4, 2012
- Quantity
- 783 units
- Distribution
- Nationwide Distribution
- Recalling firm
- Fujinon Inc, Wayne, NJ