Class 2 Device Recall ARTIS pheno

• Date Initiated by Firm: February 02, 2023
• Date Posted: March 30, 2023
• Recall Status: Open, Classified
• Recall Number: Z-1311-2023
• Recall Event ID: 91765
• 510(K)Number: K163286
• Product Classification: Interventional fluoroscopic x-ray system - Product Code OWB
• Product: ARTIS pheno systems with a Siemens Healthineers table or a Trumpf/ MAQUET table-A Fluoroscopic X-Ray system. Material # 10849000.
• Code Information: UDI #: 4056869046877 Serial Numbers: 164011 164013 164018 164019 164021 164022 164024 164025 164026 164027 164028 164033 164034 164048 164049 164053 164054 164055 164057 164060 164061 164063 164064 164066 164068 164069 164071 164072 164073 164074 164075 164080 164083 164084 164086 164094 164095 164097 164098 164100 164105 164113 164115 164121 164124 164125 164134 164138 164140 164142 164152 164153 164155 164157 164158 164159 164160 164161 164163 164168 164171 164172 164173 164183 164184 164186 164187 164188 164189 164190 164196 164201 164202 164204 164205 164210 164211 164212 164213 164216 164227 164228 164231 164234 164240 164241 164242 164244 164250 164253 164263 164267 164269 164270 164275 164277 164279 164282 164287 164292 164293 164295 164297 164298 164299 164300 164303 164306 164311 164312 164315 164318 164319 164321 164322 164326 164328 164329 164330 164331 164332 164333 164338 164340 164344 164352 164353 164355 164359 164362 164366 164371 164377 164389 164391 164394 164397 164398 164399 164400 164403
• FEI Number: 2240869
• 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: In the event of any unintended table movement, the system may not detect the incorrect direction, could lead to the injury of a patient, staff member, operator, or equipment.
• FDA Determined Cause: Software design
• Action: Siemens Healthcare issued A Customer Safety Advisory Notice distributed to customers on 2/2/23 via AX041/22/S. 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. Letter states reason for recall, health risk and action to take: Please perform system movements with adequate care to avoid injuries to persons and damage to equipment due to collisions or crushing. 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. By signing this document, you are acknowledging that you have read and understand the content.
• Quantity in Commerce: 141 units US
• 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