Class 2 Device Recall Siemens

• Date Initiated by Firm: May 27, 2021
• Create Date: July 07, 2021
• Recall Status: Open, Classified
• Recall Number: Z-2029-2021
• Recall Event ID: 88216
• 510(K)Number: K163286 K201156
• Product Classification: Interventional fluoroscopic x-ray system - Product Code OWB
• Product: ARTIS pheno- angiography systems developed for single and biplane diagnostic imaging and interventional procedures.; Model: 10849000
• Code Information: Software VE10B. Serial Numbers: 164138 164159 164033 164287 164282 164210 164183 164184 164311 164142 164071 164328 164034 164318 164244 164242 164306 164155 164189 164271 164277 164173 164292 164231 164057 164054 164055 164080 164132 164329 164072 164088 164190 164333 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 164124 164125 164279 164075 164074 164084 164086 164098 164028 164153 164330 164295 164234 164321 164270 164275 164315 164163 164158 164053 164171 164134 164253 164188 164063 164064 164299 164300 164105 164160 164024 164049 164240 164227 164228 164018 164022 164250 164061 164187 164115 164322 164269 164303 164204 164205 164211 164212 164216 164196 164168 164319 164201 164202
• Recalling Firm/ Manufacturer: Siemens Medical Solutions USA, Inc; 40 Liberty Blvd; Malvern PA 19355
• For Additional Information Contact: SAME; 610-219-4834
• Manufacturer Reason for Recall: Software error VE10B -In case of a fault within the drivetrain of an axis and while performing a stepped peripheral imaging (PERISTEPPING/PERIVISION), the C-arm may leave its intended travel path by up to 22 cm (9") result in canceling clinical treatment or to continue treatment on an alternative system
• FDA Determined Cause: Software design
• Action: Siemens issued a Urgent Medical Device Correction Letter on 5/27/21 via AX064/20/S. Additionally, a software solution is being distributed via Update Instruction AX063/20/S to all affected customers. Letter states reason for recall, health risk and action to take: Planned procedures may have to be terminated and performed on an alternative X-ray system. Please follow the standard emergency procedures you have in place in the event of system failures. It is recommended to consider reinforcing these emergency procedures until the update has been completed. Siemens will update the affected software to prevent this non-conformity from reoccurring via Update Instruction AX063/20/S. When the system recognizes a deviation of the intended travel path, unit movements will be stopped immediately, similar to an activation of a proximity switch. 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. Following the correction, the cause is eliminated, and any recurrence of this potential fault is prevented. Acknowledge Receipt of this Safety Advisory Notice Please review, understand, and confirm acknowledgement of the information and instructions outlined in this Urgent Safety Advisory Notice. By signing this document, you are acknowledging that you have read and understand the content therein. Request that you promptly notify and instruct accordingly all the staff at your organization who need to be aware of this notice and will comply with the recommendations therein. Please ensure that this safety advisory is retained in your product related records appropriately. In addition, if you may have further distributed this product, please identify your customers, and notify them at once of this product recall. If the device has been sold and is therefore no longer in your possession, please forward this notice to the new owner.
• Quantity in Commerce: 116 units
• Distribution: US Nationwide
• 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.