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U.S. Department of Health and Human Services

Class 2 Device Recall Luminos Agile Max

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  Class 2 Device Recall Luminos Agile Max see related information
Date Initiated by Firm December 21, 2022
Date Posted February 23, 2023
Recall Status1 Open3, Classified
Recall Number Z-1165-2023
Recall Event ID 91649
510(K)Number K173639  
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
Product Luminos Agile Max with software VE10 & VF11- A diagnostic imaging system for
radiographic and fluoroscopic studies
Model Number: 10762472
Code Information UDI: N/A Serial Number 61624 61652 61659 63243 63344 64145 61664 61641 61631 61148 61171 61224 61776 61186 61014 61189 61142 61718 61036 61857 63268 61775 61078 61216 61818 61629 61067 63350 Expanded Recall 2/24/23: 61017 61021 61031 61033 61034 61037 61038 61040 61041 61045 61047 61055 61057 61059 61063 61065 61073 61074 61075 61077 61083 61094 61096 61097 61098 61099 61100 61101 61102 61112 61118 61120 61123 61125 61126 61129 61130 61131 61132 61133 61143 61152 61153 61157 61158 61160 61164 61165 61166 61168 61172 61174 61175 61177 61178 61184 61185 61191 61193 61195 61202 61203 61205 61208 61209 61210 61220 61224 61226 61230 61233 61237 61243 61245 61253 61258 61604 61606 61612 61616 61617 61618 61626 61632 61633 61639 61640 61649 61653 61654 61655 61657 61662 61664 61665 61666 61667 61671 61672 61675 61676 61678 61683 61687 61691 61700 61702 61704 61707 61708 61710 61719 61723 61724 61725 61729 61734 61736 61740 61746 61751 61753 61754 61756 61758 61761 61764 61765 61769 61772 61774 61782 61783 61784 61787 61788 61790 61793 61797 61798 61809 61811 61817 61822 61824 61826 61828 61832 61833 61835 61843 61844 61849 61852 61856 61859 61863 61874 61875 61878 61879 61882 61884 61887 61888 61889 61890 61892 61893 61894 61895 61897 63013 63014 63015 63016 63017 63020 63023 63025 63026 63027 63034 63037 63038 63043 63045 63047 63051 63054 63056 63057 63058 63064 63065 63067 63076 63077 63078 63083 63084 63086 63087 63089 63091 63096 63100 63106 63108 63110 63121 63123 63124 63127 63129 63132 63134 63135 63136 63137 63138 63142 63148 63149 63157 63159 63161 63162 63164 63165 63171 63175 63176 63179 63185 63186 63188 63190 63192 63193 63194 63195 63196 63201 63203 63209 63210 63214 63218 63220 63223 63225 63228 63234 63236 63237 63238 63245 63246 63250 63253 63259 63260 63264 63266 63271 63279 63280 63289 63290 63292 63294 63296 63297 63300 63302 63303 63309 63315 63316 63318 63319 63324 63331 63332 63345 63346 63359 63361 63362 63371 64017 64023 64038 64042 64043 64046 64048 64051 64054 64055 64059 64061 64064 64074 64076 64078 64081 64083 64090 64097 64099 64106 64110 64111 64112 64117 64118 64120 64122 64123 64124 64134 64140 64141 64146 64148 64155 64157 64158 64159 64163 64164 64165 64166 64171 64174 64176 64177 64185 64186 64188 64189 64190 64193 64194 64199 64200 64201 64206 64207 64208 64209 64210 64211 64213 64215 64217 64224 64225 64226 64231 64233 64235 64238 64239 64240 64241 64244 64250 64254 64255 64256 64258 64259 64260 64261 64262 64264 64265 64266 64267 64268 64271 64272 64273 64274 64276 64277 64278 64279 64280 64281 64282 64283 64284 64285 64286 64287 64288 64289 64290 64291 64292 64294 64298
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
40 Liberty Blvd
Malvern PA 19355-1418
For Additional Information Contact SAME
610-219-4834
Manufacturer Reason
for Recall		 Potential risk of collision with the ceiling, wall, or objects which may result in serious injury to staff or patients due to room configuration parameters of the system being set to default values
FDA Determined
Cause 2		 Software design
Action ***UPDATE*** Siemens issued Urgent Medical Device Correction letter (expansion) via CSAN XP056/22/S to affected customers on 2/24/2023. The CSAN alerts the users to the issue warning them to pay special attention to the travel range of system parts. The CSAN urges users to stop system movement to prevent collision by releasing the movement control or by activating the emergency stop button as described in the system Operator Manual. Field corrective action via XP057/22/S will initiate an onsite visit to the customer facilities by a Siemens Customer Service Engineer to check the room configuration parameters current set on the systems and, if necessary, restore them to the correct values. This service will be provided to the customers free of charge. Customers with software version VF11 will be addressed under a separate and to be determined UI (update to VF11H). If you have any technical questions or desire an earlier appointment, please contact our service organization at 1-800-888-7436. _______________________________ ___________________________________________ Siemens Medical Solutions issued Customer Safety Advisory Notification( CSAN XP053/22/S) beginning on December 21, 2022. Letter states reason for recall, health risk and action to take: When performing unit movements, the user should pay special attention to the travel range of the system parts and stop movement in time to prevent a collision with the ceiling, wall, or objects. System movement can be stopped by releasing the movement control or by activating the emergency stop button as described in the system Operator Manual. Customer Safety Advisory Notice (XP053/22/S) will be distributed to all affected customers. Field corrective action via XP054/22/S will initiate an onsite visit of a Siemens Customer Service Engineer to check the room configuration parameters currently set for your system and if necessary, restore them to the correct values. These visits will be free of charge. The Siemens Service Or
Quantity in Commerce 28 units. Expanded Recall: 506 units
Distribution US Nationwide distribution.
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 = OWB and Original Applicant = Siemens Medical Solutions, Inc
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