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U.S. Department of Health and Human Services

Class 2 Device Recall ARTIS pheno

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  Class 2 Device Recall ARTIS pheno see related information
Date Initiated by Firm September 20, 2022
Date Posted October 21, 2022
Recall Status1 Open3, Classified
Recall Number Z-0119-2023
Recall Event ID 90904
510(K)Number K163286  
Product Classification System, x-ray, fluoroscopic, image-intensified - Product Code JAA
Product ARTIS pheno, Interventional fluoroscopic x-ray system, Model No. 10849000
Code Information UDI-DI: 04056869046877 Serial No 164140 164138 164159 164331 164332 164033 164287 164282 164210 164183 164184 164311 164312 164328 164034 164391 164318 164244 164306 164155 164340 164189 164271 164277 164173 164292 164231 164095 164057 164054 164055 164132 164329 164072 164190 164048 164025 164026 164027 164338 164094 164241 164326 164267 164186 164068 164121 164157 164019 164152 164161 164013 164069 164213 164073 164257 164293 164263 164298 164060 164083 164113 164021 164066 164362 164398 164124 164125 164366 164279 164075 164074 164084 164086 164098 164153 164330 164389 164394 164172 164295 164353 164234 164321 164242 164270 164275 164315 164344 164163 164158 164053 164171 164297 164134 164253 164333 164188 164377 164063 164064 164397 164299 164300 164105 164160 164024 164080 164049 164240 164359 164227 164228 164018 164022 164250 164061 164187 164115 164399 164011 164204 164205 164211 164212 164216 164100 164097 164269 164303 164322 164400 164196 164355 164352 164168 164319 164201 164202 164371
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
40 Liberty Blvd
Malvern PA 19355-1418
For Additional Information Contact Meredith Adams
610-219-4834
Manufacturer Reason
for Recall		 Siemens has become aware of three potential software issues with ARTIS pheno systems with software version VE10B. This may lead to a hazardous situation for patients if treatment cannot be continued on the system and treatment needs to be continued on an alternate system.
FDA Determined
Cause 2		 Software design
Action On September 20, 2022, the firm notified affected customers via Urgent Medical Device Correction letters. This notification covered three issues. 1. System Error Management, in which the operator is unable to release X-Ray in "Bypass fluoroscopy" mode which remains permanently inhibited, and may result in a situation where it is necessary to cancel clinical treatment or to continue treatment on an alternative system. Customers should ensure that patient treatment can be continued in other ways if there is any possible danger for the safety of the patient. 2. Head Holder Symbols, in which the user cannot tell whether a head holder has been selected in the system, may lead to a collision between the C-Arm and the head holder during system movement if the head holder is being used but not selected on the system. Customers should ensure that the configuration of the head holder is correct prior to system movements and double check configuration in the control room in case of uncertainty during the procedure. 3. Stand Movement, in which rarely no stand movement is possible after a routine brake test, leading to a possible delay of procedure. Customers should carry out routine brake tests with sufficient time before starting any procedure. Siemens will correct the software errors and contact customers to arrange a date to perform the corrective action. Please feel free to contact Siemens' service organization for an earlier appointment at 1-800-888-7436.
Quantity in Commerce 140 US
Distribution Domestic distribution nationwide. Foreign distribution worldwide.
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 = JAA and Original Applicant = SIEMENS MEDICAL SOLUTION USA, INC.
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