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U.S. Department of Health and Human Services

Medical Device Recalls

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 Class 2 Recall
EPX4400, EPX4400HDVideo Processor
see related information
Date Posted February 09, 2011
Recall Status1 Terminated on June 04, 2012
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.
Code Information DEvice Listing #D059810 V491A244 1V491A106 1V491A166 1V491A167 1V491A168 1V491A175 1V491A451 1V491A454 1V491A353 1V491A356 1V491A134 1V491A162 1V491A163 1V491A165 1V491A184 1V491A192 1V491A194 1V491A239 1V491A456 1V491A457 1V491A464 1V491A429 1V491A433 1V491A210 1V491A552 1V491A553 1V491A474 1V491A121 1V491A127 1V491A128 1V491A190 1V491A200 1V491A259 1V491A506 1V491A140 1V491A208 1V491A003 1V491A103 1V491A559 1V491A206 1V491A313 1V491A445 1V491A402 1V491A403 1V491A405 1V491A193 1V491A145 1V491A195 1V491A102 1V491A108 1V491A458 1V491A073 1V491A432 1V491A216 1V491A219 1V491A241 1V491A246 1V491A225 1V491A104 1V491A107 1V491A114 1V491A131 1V491A484 1V491A499 1V491A044 1V491A088 1V491A304 1V491A308 1V491A321 1V491A551 1V491A053 1V491A070 1V491A236 1V491A147 1V491A087 1V491A110 1V491A120 1V491A123 1V491A097 1V491A016 1V491A153 1V491A157 1V491A143 1V491A183 1V491A187 1V491A199 1V491A188 1V491A203 1V491A209 1V491A250 1V491A547 1V491A548 1V491A545 1V491A309 1V491A115 1V491A116 1V491A139 1V491A038 1V491A039 1V491A042 1V491A043 1V491A045 1V491A048 1V491A049 1V491A059 1V491A077 1V491A401 1V491A404 1V491A408 1V491A430 1V491A196 1V491A142 1V491A182 1V491A198 1V491A305 1V491A325 1V491A440 1V491A516 1V491A519 1V491A081 1V491A460 1V491A467 1V491A501 1V491A502 1V491A507 1V491A473 1V491A480 1V491A307 1V491A312 1V491A177 1V491A322 1V491A421 1V491A520 1V491A521 1V491A141 1V491A174 1V491A202 1V491A179 1V491A186 1V491A122 1V491A126 1V491A083 1V491A085 1V491A113 1V491A571 1V491A570 1V491A574 1V491A573 1V491A572 1V491A558 1V491A531 1V491A489 1V491A510 1V491A082 1V491A089 1V491A093 1V491A095 1V491A518 1V491A137 1V491A453 1V491A019 1V491A054 1V491A072 1V491A297 1V491A311 1V491A204 1V491A217 1V491A260 1V491A262 1V491A263 1V491A205 1V491A207 1V491A212 1V491A214 1V491A261 1V491A533 1V491A535 1V491A238 1V491A240 1V491A257 1V491A444 1V491A428 1V491A431 1V491A436 1V491A426 1V491A427 1V491A033 1V491A058 1V491A201 1V491A529 1V491A532 1V491A094 1V491A001 1V491A354 1V491A361 1V491A365 1V491A366 1V491A367 1V491A368 1V491A369 1V491A378 1V491A379 1V491A380 1V491A381 1V491A382 1V491A446 1V491A463 1V491A438 1V491A505 1V491A526 1V491A555 1V491A471 1V491A197 1V491A004 1V491A009 1V491A014 1V491A030 1V491A032 1V491A034 1V491A528 1V491A556 1V491A557 1V491A483 1V491A133 1V491A159 1V491A160 1V491A161 1V491A169 1V491A176 1V491A155 1V491A067 1V491A079 1V491A084 1V491A086 1V491A091 1V491A092 1V491A180 1V491A228 1V491A101 1V491A513 1V491A514 1V491A536 1V491A538 1V491A539 1V491A503 1V491A504 1V491A508 1V491A509 1V491A226 1V491A227 1V491A242 1V491A248 1V491A249 1V491A222 1V491A223 1V491A235 1V491A243 1V491A247 1V491A074 1V491A075 1V491A231 1V491A265 1V491A135 1V491A515 1V491A523 1V491A310 1V491A472 1V491A298 1V491A144 1V491A151 1V491A154 1V491A211 1V491A470 1V491A475 1V491A478 1V491A479 1V491A482 1V491A306 1V491A119 1V491A522 1V491A407 1V491A534 1V491A156 1V491A118 1V491A389 1V491A096 1V491A111 1V491A112 1V491A256 1V491A025 1V491A015 1V491A554 1V491A455 1V491A012 1V491A090 1V491A224 1V491A158 1V491A229 1V491A435 1V491A437 1V491A439 1V491A441 1V491A443 1V491A465 1V491A466 1V491A357 1V491A027 1V491A026 1V491A434 1V491A512 1V491A477 1V491A323 1V491A530 1V491A080 1V491A170 1V491A171 1V491A173 1V491A181 1V491A024 1V491A005 1V491A013 1V491A355 1V491A524 1V491A315 1V491A423 1V491A213 1V491A020 1V491A022 1V491A028 1V491A462 1V491A129 1V491A146 1V491A136 1V491A391 1V491A392 1V491A394 1V491A406 1V491A409 1V491A410 1V491A191 1V491A230 1V491A237 1V491A233 1V491A234 1V491A442 1V491A010 1V491A078 1V491A117 1V491A452 1V491A549 1V491A138 1V491A152 1V491A164 1V491A178 1V491A185 1V491A373 K944620 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 2V395A319 2V395A321 2V395A322 2V395A273 4V395A154 4V395A567 4V395A576 4V395A184 4V395A185 4V395A074 4V395A193 4V395A608 4V395A681 4V395A683 4V395A680 4V395A728 4V395A729 4V395A731 4V395A734 4V395A213 4V395A333 2V395A306 4V395A542 4V395A543 4V395A559 4V395A496 1V395A098 4V395A272 4V395A251 4V395A245 4V395A077 4V395A702 2V395A047 2V395A025 2V395A274 4V395A730 4V395A054 4V395A078 4V395A480 4V395A217 4V395A266 2V395A229 2V395A271 2V395A243 2V395A254 4V395A463 4V395A467 4V395A410 4V395A411 4V395A412 4V395A413 4V395A414 4V395A418 4V395A421 4V395A426 4V395A427 4V395A428 4V395A429 4V395A450 4V395A477 4V395A772 4V395A038 4V395A044 4V395A049 4V395A057 4V395A060 4V395A067 4V395A068 4V395A069 4V395A079 4V395A320 4V395A214 4V395A219 2V395A108 2V395A205 2V395A210 2V395A255 4V395A452 4V395A443 4V395A444 4V395A445 4V395A570 2V395A002 2V395A003 2V395A004 2V395A250 2V395A259 2V395A260 2V395A262 2V395A275 2V395A282 2V395A284 2V395A286 2V395A287 2V395A288 2V395A289 2V395A290 2V395A291 2V395A292 4V395A750 2V395A151 4V395A606 4V395A700 4V395A701 2V395A068 2V395A230 2V395A231 2V395A234 4V395A553 1V395A100 1V395A102 1V395A107 2V395A074 2V395A214 4V395A189 4V395A215 4V395A555 4V395A735 4V395A746 2V395A279 2V395A050 4V395A306 4V395A566 4V395A574 2V395A049 2V395A147 2V395A017 2V395A159 4V395A153 4V395A601 2V395A071 2V395A076 4V395A308 2V395A152 2V395A153 4V395A550 4V395A175 4V395A176 4V395A721 2V395A212 4V395A632 4V395A575 1V395A112 4V395A300 4V395A301 4V395A686 4V395A687 4V395A073 4V395A075 4V395A552 4V395A627 1V395A109 1V395A115 2V395A021 4V395A338 2V395A155 2V395A300 2V395A302 4V395A088 4V395A254 4V395A275 4V395A275 4V395A605 4V395A609 4V395A224 4V395A331 4V395A337 4V395A248 2V395A261 2V395A277 4V395A106 4V395A113 2V395A242 2V395A251 2V395A252 2V395A218 2V395A219 4V395A138 4V395A249 4V395A257 4V395A313 4V395A314 4V395A315 2V395A042 4V395A307 4V395A312 4V395A497 2V395A317 2V395A320 2V395A323 2V395A326 2V395A327 2V395A016 1V395A103 2V395A006 4V395A434 4V395A216 4V395A363 4V395A246 4V395A246 4V395A364 2V395A268 2V395A272 4V395A173 4V395A188 2V395A237 4V395A523 4V395A569 4V395A235 4V395A613 4V395A510 4V395A564 4V395A573 4V395A579 4V395A227 2V395A253 2V395A278 2V395A280 2V395A012 2V395A015 2V395A020 2V395A024 4V395A247 4V395A265 4V395A086 4V395A304 EPX-4400HD - Catalog Number 5900094 1V491A537 1V491A125 1V491A132 1V491A150 1V491A525 1V491A476 1V491A481 1V491A220 1
Recalling Firm/
Fujinon Inc
10 Highpoint Dr
Wayne, New Jersey 07470
For Additional Information Contact Ms. Gina Walljasper
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.
FDA Determined
Cause 2
PREMARKET APPROVAL: No Marketing Application
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
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.