Device Recall Cirrus HDOCT Model 400 instruments

Software kit part number: 2660021140099 (US and OUS): part number 2660021140811 - China: Serial numbers: 400-10225 400-10220 400-10216 400-10281 400-10256 400-10212 400-10258 400-10278 400-10211 400-10262 400-10676 400-10269 400-10139 400-10261 400-10223 400-10286 400-10253 400-10296 400-10277 400-10082 400-10299 400-10266 400-10188 400-10319 400-10297 400-10591 400-10798 400-10493 400-10750 400-10733 400-10355 400-10058 400-10549 400-10617 400-10071 400-10115 400-10130 400-10457 400-10273 400-10003 400-10646 400-10486 400-11037 400-10275 400-10072 400-10772 400-10516 400-10218 400-10082 400-10316 400-10000 400-10001 400-10002 400-10004 400-10005 400-10006 400-10007 400-10008 400-10009 400-10011 400-10012 400-10014 400-10016 400-10019 400-10021 400-10024 400-10027 400-10028 400-10029 400-10030 400-10035 400-10037 400-10043 400-10044 400-10045 400-10046 400-10048 400-10051 400-10052 400-10054 400-10055 400-10059 400-10061 400-10064 400-10066 400-10069 400-10073 400-10074 400-10076 400-10081 400-10083 400-10084 400-10085 400-10087 400-10088 400-10089 400-10090 400-10092 400-10095 400-10096 400-10099 400-10104 400-10105 400-10108 400-10109 400-10110 400-10111 400-10112 400-10113 400-10116 400-10117 400-10118 400-10119 400-10121 400-10123 400-10124 400-10125 400-10126 400-10127 400-10128 400-10129 400-10131 400-10132 400-10133 400-10134 400-10135 400-10136 400-10137 400-10138 400-10140 400-10141 400-10142 400-10144 400-10145 400-10146 400-10148 400-10149 400-10152 400-10156 400-10158 400-10159 400-10161 400-10162 400-10163 400-10164 400-10165 400-10166 400-10167 400-10168 400-10169 400-10170 400-10171 400-10172 400-10173 400-10175 400-10177 400-10179 400-10180 400-10181 400-10182 400-10183 400-10184 400-10185 400-10186 400-10187 400-10190 400-10191 400-10192 400-10194 400-10195 400-10196 400-10197 400-10199 400-10202 400-10234 400-10237 400-10239 400-10240 400-10241 400-10242 400-10243 400-10244 400-10245 400-10246 400-10248 400-10252 400-10263 400-10272 400-10274 400-10276 400-10279 400-10283 400-10294 400-10298 400-10307 400-10326 400-10328 400-10329 400-10334 400-10336 400-10337 400-10338 400-10340 400-10341 400-10343 400-10354 400-10357 400-10360 400-10361 400-10366 400-10372 400-10373 400-10374 400-10375 400-10377 400-10378 400-10382 400-10383 400-10384 400-10385 400-10386 400-10388 400-10389 400-10391 400-10393 400-10394 400-10395 400-10397 400-10400 400-10403 400-10404 400-10420 400-10425 400-10426 400-10433 400-10434 400-10445 400-10447 400-10449 400-10451 400-10452 400-10453 400-10454 400-10458 400-10459 400-10460 400-10467 400-10471 400-10474 400-10475 400-10477 400-10478 400-10482 400-10483 400-10484 400-10485 400-10487 400-10488 400-10489 400-10490 400-10491 400-10492 400-10494 400-10495 400-10496 400-10497 400-10498 400-10499 400-10501 400-10502 400-10504 400-10505 400-10506 400-10507 400-10508 400-10509 400-10510 400-10511 400-10512 400-10513 400-10514 400-10515 400-10518 400-10521 400-10522 400-10524 400-10525 400-10526 400-10528 400-10529 400-10532 400-10539 400-10542 400-10543 400-10544 400-10548 400-10550 400-10552 400-10556 400-10557 400-10561 400-10562 400-10595 400-10600 400-10603 400-10606 400-10610 400-10612 400-10614 400-10615 400-10620 400-10625 400-10626 400-10627 400-10628 400-10629 400-10630 400-10631 400-10632 400-10633 400-10635 400-10638 400-10640 400-10643 400-10645 400-10648 400-10649 400-10650 400-10652 400-10662 400-10666 400-10668 400-10669 400-10670 400-10671 400-10672 400-10673 400-10674 400-10675 400-10677 400-10678 400-10679 400-10680 400-10682 400-10685 400-10687 400-10688 400-10689 400-10690 400-10695 400-10696 400-10697 400-10698 400-10699 400-10700 400-10701 400-10702 400-10703 400-10704 400-10705 400-10707 400-10708 400-10709 400-10711 400-10712 400-10713 400-10714 400-10715 400-10716 400-10719 400-10720 400-10721 400-10722 400-10725 400-10728 400-10731 400-10734 400-10735 400-10739 400-10741 400-10742 400-10743 400-10753 400-10758 400-10759 400-10765 400-10773 400-10790 400-10792 400-10793 400-10795 400-10796 400-10797 400-11007 400-11010 400-11019 400-11022 400-11034 400-11035 400-11036 400-11039 400-11040 400-11041 400-10225 400-10220 400-10216 400-10281 400-10256 400-10212 400-10258 400-10278 400-10211 400-10262 400-10676 400-10269 400-10139 400-10261 400-10223 400-10286 400-10253 400-10296 400-10277 400-10082 400-10299 400-10266 400-10188 400-10319 400-10297 400-10591 400-10798 400-10493 400-10750 400-10733 400-10355 400-10058 400-10549 400-10617 400-10071 400-10115 400-10130 400-10457 400-10273 400-10003 400-10646 400-10486 400-11037 400-10275 400-10072 400-10772 400-10516 400-10218 400-10082 400-10316 400-10000 400-10001 400-10002 400-10004 400-10005 400-10006 400-10007 400-10008 400-10009 400-10011 400-10012 400-10014 400-10016 400-10019 400-10021 400-10024 400-10027 400-10028 400-10029 400-10030 400-10035 400-10037 400-10043 400-10044 400-10045 400-10046 400-10048 400-10051 400-10052 400-10054 400-10055 400-10059 400-10061 400-10064 400-10066 400-10069 400-10073 400-10074 400-10076 400-10081 400-10083 400-10084 400-10085 400-10087 400-10088 400-10089 400-10090 400-10092 400-10095 400-10096 400-10099 400-10104 400-10105 400-10108 400-10109 400-10110 400-10111 400-10112 400-10113 400-10116 400-10117 400-10118 400-10119 400-10121 400-10123 400-10124 400-10125 400-10126 400-10127 400-10128 400-10129 400-10131 400-10132 400-10133 400-10134 400-10135 400-10136 400-10137 400-10138 400-10140 400-10141 400-10142 400-10144 400-10145 400-10146 400-10148 400-10149 400-10152 400-10156 400-10158 400-10159 400-10161 400-10162 400-10163 400-10164 400-10165 400-10166 400-10167 400-10168 400-10169 400-10170 400-10171 400-10172 400-10173 400-10175 400-10177 400-10179 400-10180 400-10181 400-10182 400-10183 400-10184 400-10185 400-10186 400-10187 400-10190 400-10191 400-10192 400-10194 400-10195 400-10196 400-10197 400-10199 400-10202 400-10234 400-10237 400-10239 400-10240 400-10241 400-10242 400-10243 400-10244 400-10245 400-10246 400-10248 400-10252 400-10263 400-10272 400-10274 400-10276 400-10279 400-10283 400-10294 400-10298 400-10307 400-10326 400-10328 400-10329 400-10334 400-10336 400-10337 400-10338 400-10340 400-10341 400-10343 400-10354 400-10357 400-10360 400-10361 400-10366 400-10372 400-10373 400-10374 400-10375 400-10377 400-10378 400-10382 400-10383 400-10384 400-10385 400-10386 400-10388 400-10389 400-10391 400-10393 400-10394 400-10395 400-10397 400-10400 400-10403 400-10404 400-10420 400-10425 400-10426 400-10433 400-10434 400-10445 400-10447 400-10449 400-10451 400-10452 400-10453 400-10454 400-10458 400-10459 400-10460 400-10467 400-10471 400-10474 400-10475 400-10477 400-10478 400-10482 400-10483 400-10484 400-10485 400-10487 400-10488 400-10489 400-10490 400-10491 400-10492 400-10494 400-10495 400-10496 400-10497 400-10498 400-10499 400-10501 400-10502 400-10504 400-10505 400-10506 400-10507 400-10508 400-10509 400-10510 400-10511 400-10512 400-10513 400-10514 400-10515 400-10518 400-10521 400-10522 400-10524 400-10525 400-10526 400-10528 400-10529 400-10532 400-10539 400-10542 400-10543 400-10544 400-10548 400-10550 400-10552 400-10556 400-10557 400-10561 400-10562 400-10595 400-10600 400-10603 400-10606 400-10610 400-10612 400-10614 400-10615 400-10620 400-10625 400-10626 400-10627 400-10628 400-10629 400-10630 400-10631 400-10632 400-10633 400-10635 400-10638 400-10640 400-10643 400-10645 400-10648 400-10649 400-10650 400-10652 400-10662 400-10666 400-10668 400-10669 400-10670 400-10671 400-10672 400-10673 400-10674 400-10675 400-10677 400-10678 400-10679 400-10680 400-10682 400-10685 400-10687 400-10688 400-10689 400-10690 400-10695 400-10696 400-10697 400-10698 400-10699 400-10700 400-10701 400-10702 400-10703 400-10704 400-10705 400-10707 400-10708 400-10709 400-10711 400-10712 400-10713 400-10714 400-10715 400-10716 400-10719 400-10720 400-10721 400-10722 400-10725 400-10728 400-10731 400-10734 400-10735 400-10739 400-10741 400-10742 400-10743 400-10753 400-10758 400-10759 400-10765 400-10773 400-10790 400-10792 400-10793 400-10795 400-10796 400-10797 400-11007 400-11010 400-11019 400-11022 400-11034 400-10225 400-10220 400-10216 400-10281 400-10256 400-10212 400-10258 400-10278 400-10211 400-10262 400-10676 400-10269 400-10139 400-10261 400-10223 400-10286 400-10253 400-10296 400-10277 400-10082 400-10299 400-10266 400-10188 400-10319 400-10297 400-10591 400-10798 400-10493 400-10750 400-10733 400-10355 400-10058 400-10549 400-10617 400-10071 400-10115 400-10130 400-10457 400-10273 400-10003 400-10646 400-10486 400-11037 400-10275 400-10072 400-10772 400-10516 400-10218 400-10082 400-10316 400-10000 400-10001 400-10002 400-10004 400-10005 400-10006 400-10007 400-10008 400-10009 400-10011 400-10012 400-10014 400-10016 400-10019 400-10021 400-10024 400-10027 400-10028 400-10029 400-10030 400-10035 400-10037 400-10043 400-10044 400-10045 400-10046 400-10048 400-10051 400-10052 400-10054 400-10055 400-10059 400-10061 400-10064 400-10066 400-10069 400-10073 400-10074 400-10076 400-10081 400-10083 400-10084 400-10085 400-10087 400-10088 400-10089 400-10090 400-10092 400-10095 400-10096 400-10099 400-10104 400-10105 400-10108 400-10109 400-10110 400-10111 400-10112 400-10113 400-10116 400-10117 400-10118 400-10119 400-10121 400-10123 400-10124 400-10125 400-10126 400-10127 400-10128 400-10129 400-10131 400-10132 400-10133 400-10134 400-10135 400-10136 400-10137 400-10138 400-10140 400-10141 400-10142 400-10144 400-10145 400-10146 400-10148 400-10149 400-10152 400-10156 400-10158 400-10159 400-10161 400-10162 400-10163 400-10164 400-10165 400-10166 400-10167 400-10168 400-10169 400-10170 400-10171 400-10172 400-10173 400-10175 400-10177 400-10179 400-10180 400-10181 400-10182 400-10183 400-10184 400-10185 400-10186 400-10187 400-10190 400-10191 400-10192 400-10194 400-10195 400-10196 400-10197 400-10199 400-10202 400-10234 400-10237 400-10239 400-10240 400-10241 400-10242 400-10243 400-10244 400-10245 400-10246 400-10248 400-10252 400-10263 400-10272 400-10274 400-10276 400-10279 400-10283 400-10294 400-10298 400-10307 400-10326 400-10328 400-10329 400-10334 400-10336 400-10337 400-10338 400-10340 400-10341 400-10343 400-10354 400-10357 400-10360 400-10361 400-10366 400-10372 400-10373 400-10374 400-10375 400-10377 400-10378 400-10382 400-10383 400-10384 400-10385 400-10386 400-10388 400-10389 400-10391 400-10393 400-10394 400-10395 400-10397 400-10400 400-10403 400-10404 400-10420 400-10425 400-10426 400-10433 400-10434 400-10445 400-10447 400-10449 400-10451 400-10452 400-10453 400-10454 400-10458 400-10459 400-10460 400-10467 400-10471 400-10474 400-10475 400-10477 400-10478 400-10482 400-10483 400-10484 400-10485 400-10487 400-10488 400-10489 400-10490 400-10491 400-10492 400-10494 400-10495 400-10496 400-10497 400-10498 400-10499 400-10501 400-10502 400-10504 400-10505 400-10506 400-10507 400-10508 400-10509 400-10510 400-10511 400-10512 400-10513 400-10514 400-10515 400-10518 400-10521 400-10522 400-10524 400-10525 400-10526 400-10528 400-10529 400-10532 400-10539 400-10542 400-10543 400-10544 400-10548 400-10550 400-10552 400-10556 400-10557 400-10561 400-10562 400-10595 400-10600 400-10603 400-10606 400-10610 400-10612 400-10614 400-10615 400-10620 400-10625 400-10626 400-10627 400-10628 400-10629 400-10630 400-10631 400-10632 400-10633 400-10635 400-10638 400-10640 400-10643 400-10645 400-10648 400-10649 400-10650 400-10652 400-10662 400-10666 400-10668 400-10669 400-10670 400-10671 400-10672 400-10673 400-10674 400-10675 400-10677 400-10678 400-10679 400-10680 400-10682 400-10685 400-10687 400-10688 400-10689 400-10690 400-10695 400-10696 400-10697 400-10698 400-10699 400-10700 400-10701 400-10702 400-10703 400-10704 400-10705 400-10707 400-10708 400-10709 400-10711 400-10712 400-10713 400-10714 400-10715 400-10716 400-10719 400-10720 400-10721 400-10722 400-10725 400-10728 400-10731 400-10734 400-10735 400-10739 400-10741 400-10742 400-10743 400-10753 400-10758 400-10759 400-10765 400-10773 400-10790 400-10792 400-10793 400-10795 400-10796 400-10797 400-11007 400-11010 400-11019 400-11022 400-11034 400-11035 400-11036 400-11039 400-11040 400-11041 400-10305 400-10318 400-10176 400-10236 400-10684 400-10282 400-10292 400-10260 400-10613 400-11035 400-11036 400-11039 400-11040 400-11041 400-10305 400-10318 400-10176 400-10236 400-10684 400-10282 400-10292 400-10260 400-10312 400-10300 400-10201 400-10065 400-10025 400-10034; International: 400-10080 400-10094 400-10107 400-10122 400-10203 400-10267 400-10302 400-10381 400-10664 400-10249 400-10270 400-10015 400-10017 400-10018 400-10020 400-10022 400-10023 400-10047 400-10050 400-10053 400-10056 400-10060 400-10379 400-10380 400-10392 400-10540 400-10607 400-10661 400-10686 400-10738 400-10740 400-10776 400-10788 400-10789 400-10559 400-10413 400-10691 400-10692 400-10693 400-10694 400-10724 400-10756 400-11012 400-11013 400-11015 400-11016 400-11026 400-10031 400-10032 400-10033 400-10036 400-10038 400-10040 400-10041 400-10042 400-10049 400-10057 400-10068 400-10070 400-10077 400-10078 400-10093 400-10097 400-10098 400-10101 400-10102 400-10106 400-10150 400-10153 400-10154 400-10155 400-10157 400-10198 400-10221 400-10227 400-10228 400-10229 400-10230 400-10233 400-10255 400-10271 400-10284 400-10310 400-10315 400-10323 400-10324 400-10335 400-10344 400-10345 400-10347 400-10351 400-10387 400-10390 400-10396 400-10398 400-10399 400-10415 400-10429 400-10430 400-10432 400-10438 400-10439 400-10440 400-10441 400-10442 400-10455 400-10456 400-10465 400-10469 400-10472 400-10481 400-10517 400-10519 400-10520 400-10523 400-10530 400-10531 400-10533 400-10534 400-10535 400-10536 400-10537 400-10538 400-10541 400-10545 400-10546 400-10551 400-10553 400-10555 400-10558 400-10560 400-10583 400-10584 400-10585 400-10587 400-10592 400-10599 400-10602 400-10604 400-10605 400-10608 400-10611 400-10616 400-10618 400-10619 400-10621 400-10622 400-10623 400-10624 400-10636 400-10639 400-10642 400-10644 400-10647 400-10651 400-10653 400-10654 400-10655 400-10656 400-10657 400-10658 400-10659 400-10660 400-10663 400-10665 400-10667 400-10706 400-10717 400-10723 400-10727 400-10729 400-10732 400-10744 400-10746 400-10747 400-10748 400-10760 400-10784 400-10785 400-10786 400-10787 400-10794 400-11000 400-11001 400-11002 400-11003 400-11004 400-11005 400-11006 400-11008 400-11009 400-10174 400-10250 400-10290 400-10306 400-10443 400-10444 400-10446 400-10479 400-10554 400-10634 400-10637 400-10641 400-10710 400-10718 400-10745 400-10777 400-10791 400-11033 400-10026 400-10039 400-10062 400-10079 400-10086 400-10091 400-10100 400-10103 400-10147 400-10151 400-10200 400-10204 400-10205 400-10206 400-10207 400-10209 400-10210 400-10215 400-10217 400-10219 400-10222 400-10226 400-10235 400-10288 400-10308 400-10311 400-10321 400-10327 400-10330 400-10331 400-10332 400-10333 400-10339 400-10342 400-10346 400-10348 400-10349 400-10350 400-10352 400-10356 400-10358 400-10359 400-10362 400-10363 400-10364 400-10365 400-10367 400-10368 400-10369 400-10370 400-10371 400-10376 400-10401 400-10402 400-10405 400-10406 400-10407 400-10409 400-10410 400-10411 400-10414 400-10416 400-10417 400-10418 400-10419 400-10421 400-10422 400-10423 400-10424 400-10427 400-10428 400-10431 400-10435 400-10436 400-10437 400-10448 400-10450 400-10461 400-10462 400-10463 400-10464 400-10466 400-10468 400-10470 400-10473 400-10476 400-10527 400-10547 400-10563 400-10564 400-10565 400-10566 400-10567 400-10568 400-10569 400-10570 400-10571 400-10572 400-10573 400-10574 400-10575 400-10576 400-10577 400-10578 400-10579 400-10580 400-10581 400-10582 400-10586 400-105876 400-10588 400-10589 400-10590 400-10593 400-10596 400-10597 400-10598 400-10601 400-10726 400-10736 400-10751 400-10752 400-10754 400-10755 400-10757 400-10761 400-10762 400-10763 400-10764 400-10766 400-10767 400-10768 400-10769 400-10770 400-10771 400-10774 400-10775 400-10778 400-10779 400-10780 400-10781 400-10782 400-10783 400-11011 400-11017 400-11018 400-11020 400-11021 400-11024 400-11025 400-11027 400-11028 400-11029 400-11030 400-11031 400-11043 400-10063 400-10075 400-10178.

Ophthalmic Devices

2

No

Worldwide Distribution - USA including AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, LA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SC, TN, TX, UT, VA, VT, WA, WI, and WV, and the countries of Algeria, Argentina, Australia, Bangladesh, Belgium, Boliva, Brazil, Canada, France, Chili, China, Columbia, Denmark, Ecuador,Germany, Great Britain, Greece, Guatemala, Hong Kong, India, Japan, Lebanon, Malaysia, Mexico, New Zealand, Pakistan, Peru, Singapore,South Korea, Spain, Sri Lanka, Taiwan, Uruguay and Venezuela

Cirrus HD-OCT Model 400 instruments; new and refurbished, with or upgraded to, version 4.6 or 5.1.0 software. || The Cirrus HD-OCT is a non-contact, high resolution tomographic and biomicroscopic imaging device.