Hologic, Inc.

Serial numbers per recall strategy.

Radiology Devices

2

No

Worldwide distribution: USA (nationwide) and countries of: DE, RU, AU, IT, GB, ES, FR, KR, ZA, CA, AR, LT, TW, CN, BE, AT, JP, QA, SA, SG, HK, SI, NL, and SE.

Fluoroscan Mini C-arm InSight, software versions 1.x, 2.x, 3.x || The device is a Mini C-arm Fluroscopic Imaging System designed to provide physicians with general fluoroscopic visualization of a patient, including but no limited to surgical orthopedic and podiatry use, critical and emergency procedures, and light anatomy imaging situation.

Serial numbers per recall strategy.

Radiology Devices

2

No

Worldwide distribution: USA (nationwide) and countries of: DE, RU, AU, IT, GB, ES, FR, KR, ZA, CA, AR, LT, TW, CN, BE, AT, JP, QA, SA, SG, HK, SI, NL, and SE.

Fluoroscan Mini C-arm InSight2, software versions 3.x, 4.0, 4.0.1, 4.0.2 || The device is a Mini C-arm Fluroscopic Imaging System designed to provide physicians with general fluoroscopic visualization of a patient, including but no limited to surgical orthopedic and podiatry use, critical and emergency procedures, and light anatomy imaging situation.

S/N: Office Mate: 02089805 02109804 02109903 02089810 02079802 09971484 05039816 05119832 02-0103-03 02080007 02129812 06971402 02119912 05039824 05129914 05079811 02079901 02059910 02129905 02069932 10971491 02-0104-01 02039805 02049920 02-0103-01 02-1202-03 02109806 09971460 11971502 02-0204-01 02-0304-01 02-0903-01 02059814 03-0602-04 06-0301-01 02109809 12971511 02-1103-01 02119814 02049809 02049803 02-1103-02 06971416 02040004 02-0803-01 02099817 02-0698-01 02070007 02069902 02090002 02039820 02069808 10971496 02-0603-04 02030123 02110014 07971423 12971509 09971463 02019806 09971465 02120201 05010003 05039833 05039834 05079805 05079808 05079809 05079816 05129916 05129917 05129918 05129921 05129922 05129923 05129924 05129930 05129931 05129932 07971435 08971437 08971442 08971444 08971445 08971446 06971401 05079814 09971471 02059914 02110003 09971485 07971419 05010111 05-0101-11 02039925 05079813 02039922 02040009 02109807 05129813 02040106 02039803 02089804 09971462 05129919 07971421 02109812 04971800 02030013 05079807 02109821 02049816 02-0303-02 02100018 02020008 02089913 02019913 05079806 02010218 02039813 09971474 02100008 10971495 05039832 02-0403-01 06971415 02-0404-01 02-0505-01 07971424 05079817 02069810 02119810 02-1202-01 08-9714-38 05039826 05039827 05039830 05039831 05079804 08971441 08971443 02019903 02100005 02129803 02-0603-03 02079815 02079820 02099806 02-1203-01 02050003 02109805 02129904 10971492 02-0603-01 02010007 02-0602-01 02039902 02119801 02040129 02109813 02089807 FSIII: 01129911 12961374 01069909 03971541 06961191 01039907 06961194 03971430 10961328 05961183 01049819 05971828 10961347 07961212 09961318 04971564 01069804 01079818 09971466 02961097 01039819 01109822 10961337 09961322 12961373 05971830 01971409 01961088 06961187 12971518 04961152 03961122 01089814 05961181 12961377 01029801 02961090 05961164 01060013 01099803 10961348 08971452 05109816 01099805 01971388 01971410 12951076 08971455 09971483 04971798 01039812 06961192 01100001 10961339 03961136 08961286 01129811 07971434 06971411 12971515 08961304 08961303 07961211 01971393 11961350 02961109 03961129 01109811 09961321 01089812 01089817 02961108 10961327 09971461 01059810 01029805 01971397 05971823 03971540 01069803 10961349 09961310 07961220 01049810 01029806 01059807 01059806 09971459 12971512 01099802 11951048 02961115 07971429 02961093 08961306 01019810 06971407 08961297 02961099 01961080 11971506 09961325 01059803 01089816 09961319 06971406 01059812 12952941 08961277 12971517 12961372 01049815 12951070 06961166 06961198 02961096 03961141 06961200 09971468 04971543 11971504 07971433 09961312 06961199 01059802 01971399 03971418 03961121 02961104 08961294 08961302 11961348 06971412 01069807 12961371 01069922 09961311 10961334 10961343 02961089 04961163 10961331 01961087 10961338 12961378 03961127 08961279 01029804 01069811 06961184 01971386 01039810 01039811 01059805 06971409 11961359 05971825 01109814 10961329 01089813 08961300 02961112 01059815 01029803 01079819 01119823 01971385 2100014 02961107 02961116 03961132 03961134 3961140 03961144 04971567 05961171 05961176 05961410 05971829 06961204 07961210 08971454 08971457 09961313 11951046 11961355 12951072 12961380 05971826 08961291 05971820 08961290 05961166 01129830 03971539 01109817 10961341 01971382 07971427 01059804 05971821 03961142 01069935 02961101 08971447 02961117 02961103 06961202 03961139 01039806 08961280 08961283 03971419 01060001 01089801 10971489 12951064 04961149 05961168 01049804 05971824 11971503 11951049 03971537 04971797 04971818 08971453 01971387 06961190 01069812 12951073 11971500 12951069 01029807 12971521 10961345 01019807 09961317 06961185 03971428 02971417 03961146 02961091 08961296 01109802 01059813 05971822 05961173 02961114 09971470 04961148 01971411 11961352 11961367 03971429 01039801 08961295 07961221 06961203 04961161 01109808 08961284 03971427 01049808 08971450 12961381 03961118 10961340 05961167 01069802 09971487 06961195 09971486 10961332 10971490 01089803 12951052 04961160 08961299 03961135 05961178 09961314 02961111 12951077 01019804 05961179 02060204 11961358 03971431 01971413 08961293 02971415 12951071 03971422 07961222 06971403 07961209 01039814 04961150 05961180 01039808 01971394 128A4418 2B8A4B5 31CA4C3 03961131 08961287 07971428 01039823 06961186 12971514 03971420 06971404 08961305 01971383 01019801 01049807 01049916 01059811 01069914 01089907 01129802 06961197 01961082 09971479 04961157 03971421 12975752 09961323 09971481 11961353 04961158 01059808 02961094 04971801 03961123 08961278 06971408 01039809 10961335 04971793 01089809 01039836 02961105 03971432 01019803 11971508 01119828 10971498 04961159 08952566 10971494 02961113 04961153 07971430 01049814 11961360 06971410 03961137 01079903 01029802 08961288 03971426 FSIIIC (International): 03020101 03070004 03-0603-05 03079908 03010016 03-0103-01 02030218 03069931 03119901 03079912 03049805 02080201 03030018 03079902 03080015 03070011

Radiology Devices

2

No

Worldwide distribution: USA (nationwide) and countries of: Argentina, Spain, and Viet Nam.

Fluoroscan Mini C-arm, Models: FSIII, FSIIIC and Officemate || The Officemate, FSIII and FSIIIc are compact mobile fluoroscopic C-arm systems specifically designed for x-ray imaging of extremities. The systems are used by trained medical personnel, but at times are used for non medical applications. The functionality of the units is identical for the OfficeMate, FSIII and FSIIIc. Also the construction of the different models is identical. That includes the mounting of the flex arm to the cabinet and the flex arm to the C-arm. The difference between the models resides in the monitors: " Officemate has one small monitor " FSIII has two larger monitors " FSIIIc is an international version of the FSIII (power kit)

software version 7.3.0 S/N:298051183669, 29703060119, 298031083133, 298120882443, 298090882384, 29803070916, 2981070859

Radiology Devices

2

No

Worldwide Distribution-Distributed in the state of Texas and the countries Belgium, Brazil, and Canada.

Hologics SecurView DX workstation, software version 7.3.0 || intended for viewing mammography images and other imaging modalities. || SecurView DX is intended for selection, display, manipulation, filing and media interchange of multimodality images from a variety of different modality systems. It also interfaces to various image storage and printing devices, using DICOM or similar interface standards. The device used with FDA-cleared monitors may be used by a trained physician for display, manipulation, and interpretation of lossless compressed or non-compressed mammographic images for screening and diagnostic mammography, as well as any other DICOM multimodality image.

S/N's: 83286 83048 83152 83372 83361 83033 83196 83270 83333 83172 83238 83446 83217 83078 83147 83212 83374 83375 83379 83392 83394 83396 83410 83423 80199 80920 83024 83053 83232 83318 83336 83110 83183 83189 83244 83434 83056 83335 83058 83097 83113 83166 83248 83265 83266 83283 83297 83258 83359 83381 83214 83380 83274 83123 83299 83060 83104 83108 83167 83234 83247 83403 83404 83031 83103 83067 83130 83179 83208 83226 83228 83259 83275 83304 83327 83331 83389 83416 83026 83036 83042 83052 83068 83069 83124 83128 83135 83136 83143 83153 83168 83187 83188 83193 83198 83204 83215 83242 83251 83253 83319 83320 83330 83339 83345 83347 83349 83391 83393 83444 83462 83463 83127 83137 83192 83355 83307 83063 83132 83138 83250 83262 83222 83424 83016 83030 83037 83102 83140 83281 83288 83295 83433 83070 83296 83364 83383 83449 83066 83230 83289 83344 83054 83089 83099 83146 83162 82998 83117 83145 83151 83158 83284 83401 83405 83437 83443 83341 83409 83061 83071 83079 83119 83006 83101 83303 83382 83237 83073 83095 83315 82894 82997 83012 83106 83125 83180 83184 83224 83239 83325 83340 83358 83368 83461 83129 83256 83272 83049 83171 83306 83363 83402 82970 83426 83029 83414 83087 83074 82249 80006 83220 82185 83142 83287 82771 83062 83376 83267 83227 80146 83160 83155 83233 83240 83164 83280 80397 83175 83083 80246 82827 83000 83329 83004 80498 83159 82944 83269 83059 83369 83302 83210 83163 83118 83263 81256 83413 82981 80257 82811 83219 81477 83300 83308 83098 83150 83246 82110 83041 83301 83305 81646 82376 83203 83182 83377 83231 83213 83338 83425 83156 83321 83207 83322 83072 82996 83334 83442 83395 83241 83010 82933 83001 83356 82920 82437 81968 83271 83387 83348 81841 83218 83021 83115 80836 83422 83430 83440 83039 83032 83114 81633 83460 83121 83328 83255 83406 83202 83149 81897 83453 83245 83169 83195 83292 82889 82899 83116 83191 83020 83112 83445 83384 83243 83190 83260 80111 83378 83209 83084 80741 82144 83429 83278 83451 83261 81681 80514 83088 83122 83223 82038 81942 83181 83366 83337 83197 83019 82402 81478 83081 83105 83324 83013 83225 83357 81054 83092 83157 83221 83428 83457 83107 83076 83353 83279 83144 83154 83454 83047 83055 83139 83100 83458 83323 82982 83111 83211 83176 83273 83011 83064 82591 83120 81980 83447 83170 83007 83311 83252 83080 81672 83310 82979 82857 83051 83148 83276 80910 83367 83093 83040 83317 83385 82916 80395 83046 83421 83194 83432 83316 83254 83077 83023 83343 83045 81784 81787 82064 82067 83075 83342 83411 83418 83351 81287 83009 83126 83362 83400 83094 83090 83133 83134 83314 83109 83371 83365 82371 83397 83346 83017 83034 83174 83178 83038 83082 83431 83185 83386 83415 83291 83003 83131 83398 83419 83085 83285 83065 83235 83294 83173 81058 83464 82989 82134 83177 83022 83199 83309 83427 83388 83015 83293 82671 83044 81866 83350 82876 83018 83326 80392 82828 83091 83014 83186 83282 83264 83277 83249 81665 80378 83420 83216 82226 83086 82400 80079 80374 83436 81464 82426 83050 83005 83096 82992 82935 81948 82895 83025 83043 83456 82378 83360 83229 83332 80711 83161 83370 83373 83027 83035 83165 83141 83417 83205 83312 83448 83057 83028 82775 83435 83352 83008 83206 83002 80045 83390 80970 81254 83268 83313 and 83200

Radiology Devices

2

No

Nationwide Foreign: Canada Algeria, AE, Australia, Belgium,China,France, Germany, Hungary, Hong Kong, Iceland, Iran, Ireland, Israel, Italy,Japan,Korea, Kuwait, Lithuania, Mexico, Myanmar, Netherlands, Pakistan, Peru, Russia, S. Africa, Saudi Arabia, Singapore, Slovak Rep., Switzerland, Syria, Taiwan, UK

Hologic Discovery Bone Densitometers with Apex software versions 2.0, 2.1 and 2.2 is indicated for the estimate of bone mineral density, comparison of measured variables obtained from a given scan to a database of reference values, the estimation of fracture risk, vertebral deformity assessment, body composition analysis, and discrimination of bone from prosthetics.