Class 2 Device Recall ARTIS Pheno (VE2)

• Date Initiated by Firm: June 10, 2022
• Date Posted: June 27, 2022
• Recall Status: Open, Classified
• Recall Number: Z-1294-2022
• Recall Event ID: 90507
• 510(K)Number: K201156
• 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 numbers: 164140 164138 164159 164331 164332 164033 164287 164282 164210 164183 164184 164311 164142 164312 164071 164328 164034 164318 164244 164306 164155 164340 164189 164271 164277 164173 164292 164231 164095 164057 164054 164055 164132 164329 164072 164190 164048 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 164362 164124 164125 164366 164279 164075 164074 164084 164086 164098 164028 164153 164330 164172 164295 164353 164234 164321 164242 164270 164275 164315 164344 164163 164158 164053 164171 164297 164134 164253 164188 164063 164064 164299 164300 164105 164160 164024 164080 164049 164240 164359 164227 164228 164018 164022 164250 164061 164187 164115 164011 164204 164205 164211 164212 164216 164100 164097 164269 164303 164322 164196 164355 164352 164168 164319 164201 164202 ***Updated 9/13/23*** 164088 164193
• 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: A video signal from one of the transceivers of the Large Display may be lost. In very rare cases, both transceivers of the Large Display could potentially fail which can lead to the loss of both video signals. This issue can sporadically affect the Large Display in the examination room as well as the displays in the control room.
• FDA Determined Cause: Process control
• Action: Firm notified customers of the recall on June 10, 2022 via Urgent Medical Device Correction letters. The firm strongly recommends reinforcing appropriate emergency procedures until the corrective action has been performed. Please ensure that patient treatment can be continued in other ways if there is any possible danger to the safety of the patient. The firm will exchange the affected video transmission links. Their service organization will contact you shortly to arrange a date to perform this corrective action. Please feel free to contact the firm's service organization for an earlier appointment at 1-800-888-7436. The firm does not consider it necessary to re-examine any patients previously treated using the Artis pheno system.
• Quantity in Commerce: 136 systems
• Distribution: Domestic distribution nationwide. Foreign distribution to Australia Austria Belgium Brazil Canada China Colombia Denmark Finland France Germany Hungary Indonesia Iran Italy Japan Kuwait Mexico Monaco Netherlands Norway Poland Singapore Slovakia South Africa Spain Sweden Switzerland Taiwan Thailand Turkey United Arab Emirates United Kingdom United States Vietnam
• 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.