Class 2 Device Recall Hologic Discovery Bone Densitometers

• Date Initiated by Firm: June 27, 2008
• Date Posted: September 17, 2008
• Recall Status: Terminated on October 25, 2010
• Recall Number: Z-2184-2008
• Recall Event ID: 48641
• 510(K)Number: K072847
• Product Classification: Bone densitometer - Product Code KGI
• Product: 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.
• Code Information: 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
• Recalling Firm/ Manufacturer: Hologic, Inc.; 35 Crosby Dr; Bedford MA 01730-1450
• For Additional Information Contact: Lida Reed; 781-999-7300
• Manufacturer Reason for Recall: Software densitometer readings for left hip and lumbar spine under certain conditions may be inaccurate.
• FDA Determined Cause: Software design
• Action: Hologic notified customers by registered letter titled Urgent: Medical Device Recall, dated 6/27/08, providing instructions to update the software to Version 2.3 and discard version APEX 2.0, 2.1 and 2.2 manuals. If you have questions or require assistance with the software installation, contact Hologic's Help Desk at 1-800-321-4659.
• Quantity in Commerce: 534 units
• Distribution: 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
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = KGI and Original Applicant = HOLOGIC, INC.