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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 February 02, 2023
Date Posted May 02, 2023
Recall Status1 Open3, Classified
Recall Number Z-1498-2023
Recall Event ID 92046
510(K)Number K163286  
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
Product ARTIS pheno systems with a Siemens Healthineers table or Trumpf/MAQUET table (OEM)-
Angiography systems developed for single and biplane diagnostic imaging and interventional procedures.
Model: 10849000
Code Information UDI: 04056869046877 S/N: Serial # 164140 164159 164138 164332 164331 164033 164287 164282 164210 164184 164183 164311 164142 164312 164071 164328 164034 164391 164318 164244 164306 164155 164340 164189 164277 164173 164292 164231 164095 164057 164055 164054 164329 164072 164190 164048 164025 164026 164027 164338 164094 164241 164326 164267 164186 164068 164121 164157 164019 164152 164161 164013 164069 164213 164073 164293 164263 164298 164060 164083 164113 164021 164066 164398 164362 164124 164125 164366 164279 164075 164098 164028 164153 164330 164389 164394 164172 164086 164084 164074 164295 164353 164234 164321 164242 164275 164270 164315 164344 164163 164158 164053 164171 164297 164134 164253 164333 164188 164377 164403 164063 164064 164397 164300 164299 164105 164160 164024 164080 164049 164240 164359 164227 164228 164018 164022 164250 164061 164187 164115 164399 164011 164211 164216 164204 164205 164212 164100 164097 164269 164303 164322 164355 164400 164196 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 SAME
610-219-4834
Manufacturer Reason
for Recall		 If, during the procedure, X-ray has been released and a reference image has been stored, the following issue may occur: If "Adjust C-arm to Ref" is activated when the C-Arm is positioned outside of the working range the C-Arm will reach the target position with an inaccuracy of 5-10 mm. As a result, the message Endposition reached will be displayed .Leading to unintended direction of the movement causing crushing of a patient, staff member, operator, or equipmen Live images may not match the previously stored reference images. Overlay images may be shown inaccurate on anatomy (e.g., DSA Roadmap workflow does not match real anatomy). This may cause e.g., a vessel perforation in DSA roadmap.
FDA Determined
Cause 2		 Software design
Action Siemens Healthineers issued to all users of ARTIS pheno systems with a Siemens Healthineers table or Trumpf/MAQUET table (OEM) a Customer Safety Advisory Notice to affected customers via AX041/22/S dated 2/3/23. Letter states reason for recall, health risk and action to take for addressing three potential software issues: Detection of wrong table movement direction; Adjust C-arm to Ref; Missing movement stop with multiple collision sensor activation. Siemens will correct the software error via Update Instructions AX040/22/S. Our service organization will contact you shortly to arrange a date to perform this corrective action. Please feel free to contact our service organization for an earlier appointment at 1-800-888-7436. Please review, understand, and confirm acknowledgement of the information and instructions outlined in this Urgent Safety Advisory Notice. Siemens A software update to correct the error will be distributed to all affected customers via Update Instructions AX040/22/S. Affected systems will be updated to SW version VE10B.
Quantity in Commerce 141 units US
Distribution Worldwide - 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 SOLUTION USA, INC.
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