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U.S. Department of Health and Human Services

Class 2 Device Recall DXD 100

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  Class 2 Device Recall DXD 100 see related information
Date Initiated by Firm February 23, 2024
Date Posted April 02, 2024
Recall Status1 Open3, Classified
Recall Number Z-1462-2024
Recall Event ID 94143
510(K)Number K103597  
Product Classification System, x-ray, mobile - Product Code IZL
Product Agfa DX-D 100 system-Digital Radiography mobile X-ray System. A mobile X-Ray modality, consisting of X-Ray console, generator, tube, digital detector, and workstation. This modality is used to generate projection X-Ray images of human patients.

Models: 5411/ 050, A5411/ 0300 and A5411/ 0400
Code Information UDI: 5414904272725YG US Serial Numbers: Serial Number A5411001002 A5411001003 A5411001005 A5411001033 A5411001034 A5411001035 A5411001036 A5411001037 A5411001038 A5411001039 A5411001064 A5411001065 A5411001066 A5411001067 A5411001068 A5411001069 A5411001073 A5411001080 A5411001081 A5411001087 A5411001089 A5411001090 A5411001097 A5411001098 A5411001099 A5411001105 A5411001110 A5411001112 A5411001149 A5411001151 A5411001152 A5411001162 A5411001163 A5411001164 A5411001165 A5411001174 A5411001175 A5411001176 A5411001177 A5411001201 A5411002007 A5411002023 A5411002024 A5411002025 A5411002029 A5411002030 A5411002031 A5411002032 A5411002033 A5411002047 A5411002048 A5411002049 A5411002051 A5411002052 A5411002053 A5411002054 A5411002058 A5411002059 A5411002060 A5411002061 A5411002063 A5411002064 A5411002065 A5411002070 A5411002071 A5411002072 A5411002073 A5411002074 A5411002076 A5411002078 A5411002082 A5411002083 A5411002084 A5411002085 A5411002128 A5411002129 A5411002130 A5411002131 A5411002143 A5411002144 A5411002145 A5411002146 A5411002147 A5411002152 A5411002160 A5411002161 A5411002162 A5411002171 A5411002172 A5411002173 A5411002182 A5411002183 A5411002184 A5411002185 A5411002186 A5411002187 A5411002188 A5411002199 A5411002200 A5411002201 A5411002202 A5411002203 A5411002204 A5411002205 A5411002206 A5411002208 A5411002212 A5411002234 A5411002236 A5411002247 A5411002249 A5411002257 A5411002263 A5411002265 A5411002269 A5411003022 A5411003023 A5411003024 A5411003027 A5411003028 A5411003031 A5411003032 A5411003038 A5411003039 A5411003040 A5411003042 A5411003044 A5411003045 A5411003047 A5411003048 A5411003049 A5411003051 A5411003054 A5411003055 A5411003056 A5411003057 A5411003058 A5411003059 A5411003060 A5411003061 A5411003062 A5411003063 A5411003065 A5411003068 A5411003070 A5411003071 A5411003072 A5411003073 A5411003074 A5411003080 A5411003081 A5411003082 A5411003083 A5411003084 A5411003085 A5411003086 A5411003090 A5411003091 A5411003092 A5411003093 A5411003094 A5411003096 A5411003097 A5411003099 A5411003100 A5411003101 A5411003102 A5411003103 A5411003104 A5411003105 A5411003106 A5411003107 A5411003108 A5411003109 A5411003110 A5411003132 A5411003133 A5411003134 A5411003145 A5411003146 A5411003149 A5411003150 A5411003151 A5411003152 A5411003153 A5411003154 A5411003155 A5411003156 A5411003157 A5411003162 A5411003163 A5411003164 A5411003165 A5411003166 A5411003167 A5411003168 A5411003169 A5411003188 A5411003189 A5411003192 A5411003195 A5411003196 A5411003197 A5411003198 A5411003200 A5411003201 A5411003202 A5411003237 A5411003243 A5411003244 A5411003245 A5411003246 A5411003247 A5411003248 A5411003254 A5411003255 A5411003256 A5411003257 A5411003258 A5411003263 A5411003264 A5411003265 A5411003266 A5411003267 A5411003268 A5411003269 A5411003270 A5411003271 A5411003272 A5411003274 A5411003275 A5411003276 A5411003277 A5411003278 A5411003282 A5411003283 A5411003284 A5411003287 A5411003288 A5411003289 A5411003290 A5411003291 A5411003292 A5411003305 A5411003314 A5411003315 A5411003318. Canada Serial Numbers: Serial Number A5411001006 A5411002022 A5411002026 A5411002057 A5411002069 A5411002075 A5411002077 A5411002086 A5411003014 A5411003029 A5411003030 A5411003037 A5411003050 A5411003066 A5411003087 A5411003124 A5411003125 A5411003135 A5411003136 A5411003137 A5411003138 A5411003139 A5411003140 A5411003141 A5411003147 A5411003148 A5411003170 A5411003171 A5411003181 A5411003184 A5411003190 A5411003285 A5411003286. Foreign Serial Numbers: Serial Number A5411000451 A5411001000 A5411001001 A5411001004 A5411001007 A5411001012 A5411001018 A5411001031 A5411001032 A5411001041 A5411001061 A5411001062 A5411001063 A5411001074 A5411001075 A5411001076 A5411001106 A5411001107 A5411001126 A5411001127 A5411001131 A5411001132 A5411001134 A5411001137 A5411001157 A5411001158 A5411001159 A5411001160 A5411001161 A5411001193 A5411001194 A5411001195 A5411001203 A5411001207 A5411001210 A5411001211 A5411001212 A5411001213 A5411002000 A5411002001 A5411002002 A5411002003 A5411002004 A5411002005 A5411002006 A5411002008 A5411002009 A5411002010 A5411002012 A5411002013 A5411002015 A5411002016 A5411002020 A5411002021 A5411002027 A5411002028 A5411002035 A5411002036 A5411002038 A5411002039 A5411002041 A5411002055 A5411002056 A5411002062 A5411002066 A5411002067 A5411002087 A5411002088 A5411002089 A5411002090 A5411002100 A5411002101 A5411002102 A5411002103 A5411002104 A5411002105 A5411002107 A5411002116 A5411002117 A5411002118 A5411002119 A5411002120 A5411002122 A5411002123 A5411002124 A5411002125 A5411002126 A5411002127 A5411002138 A5411002140 A5411002141 A5411002142 A5411002148 A5411002149 A5411002151 A5411002154 A5411002155 A5411002156 A5411002157 A5411002168 A5411002169 A5411002174 A5411002175 A5411002176 A5411002180 A5411002191 A5411002192 A5411002209 A5411002213 A5411002214 A5411002215 A5411002220 A5411002221 A5411002225 A5411002237 A5411002238 A5411002244 A5411002251 A5411002256 A5411002261 A5411002262 A5411002264 A5411002267 A5411002268 A5411003000 A5411003001 A5411003003 A5411003004 A5411003005 A5411003006 A5411003007 A5411003008 A5411003009 A5411003011 A5411003012 A5411003013 A5411003015 A5411003016 A5411003017 A5411003018 A5411003019 A5411003020 A5411003021 A5411003025 A5411003026 A5411003034 A5411003035 A5411003036 A5411003046 A5411003053 A5411003064 A5411003067 A5411003075 A5411003077 A5411003078 A5411003079 A5411003088 A5411003089 A5411003095 A5411003098 A5411003111 A5411003113 A5411003115 A5411003116 A5411003117 A5411003118 A5411003119 A5411003120 A5411003121 A5411003122 A5411003123 A5411003126 A5411003129 A5411003130 A5411003131 A5411003142 A5411003144 A5411003158 A5411003159 A5411003160 A5411003161 A5411003172 A5411003173 A5411003174 A5411003175 A5411003176 A5411003177 A5411003178 A5411003179 A5411003182 A5411003183 A5411003185 A5411003186 A5411003187 A5411003191 A5411003193 A5411003194 A5411003199 A5411003203 A5411003204 A5411003205 A5411003206 A5411003207 A5411003208 A5411003209 A5411003210 A5411003213 A5411003214 A5411003215 A5411003216 A5411003217 A5411003218 A5411003219 A5411003220 A5411003221 A5411003222 A5411003223 A5411003224 A5411003225 A5411003226 A5411003227 A5411003228 A5411003229 A5411003230 A5411003231 A5411003232 A5411003233 A5411003234 A5411003235 A5411003236 A5411003249 A5411003250 A5411003251 A5411003252 A5411003253 A5411003259 A5411003260 A5411003261 A5411003262 A5411003273 A5411003279 A5411003280 A5411003281 A5411003294 A5411003295 A5411003296 A5411003297 A5411003298 A5411003299 A5411003300 A5411003301 A5411003304 A5411003306 A5411003307 A5411003308 A5411003309 A5411003310 A5411003311 A5411003312 A5411003316 A5411003317
Recalling Firm/
Manufacturer		 AGFA US CORP
580 Gotham Pkwy
Carlstadt NJ 07072-2405
Manufacturer Reason
for Recall		 Steel cable installed inside the mobile column which supports the weight of the telescopic arm with the tube head has potential risk -an interference could cause the safety system which blocks the arm if the cable is cut off does not work properly, may result in patient injury
FDA Determined
Cause 2		 Component design/selection
Action AGFA issued Urgent Field Safety Notice via email on 2/23/24. Letter states reason for recall, heallh risk and action to take: Agfa/local business partner will inspect the cable of your device at the earliest opportunity and will replace it in case of any potential malfunction of the safety system. If you have any questions about this matter, please contact your local Agfa NV organization/local business partner.
Quantity in Commerce 541 units
Distribution Worldwide distribution - US Nationwide and the countries of Canada, Argentina, Australia, Austria, Belgium, Chile, China, Colombia, Czech Republic, Finland, France, Germany, Greece, Italy, Kuwait, Luxembourg, Malaysia, Mexico, New Zealand, Norway, Peru, Poland, Romania, Russian Federation, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, United Kingdom.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = IZL and Original Applicant = AGFA HEALTHCARE N.V.
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