Class 2 Device Recall Artis Zee/Zeego & Artis Q/Q.Zen

• Date Initiated by Firm: June 12, 2019
• Create Date: July 22, 2019
• Recall Status: Terminated on September 18, 2020
• Recall Number: Z-2034-2019
• Recall Event ID: 83203
• 510(K)Number: K181407
• Product Classification: Interventional fluoroscopic x-ray system - Product Code OWB
• Product: Artis zeego, Model Number 10280959
• Code Information: Serial Numbers: 160395 160484 160502 160351 160392 160449 160463 160313 160411 160406 160106 160134 160136 160347 160312 160488 160448 160427 160455 160486 160435 160451 160346 160384 160100 160493 160391 160321 160376 160447 160471 160481 160401 160119 160403 160404 160501 160438 160388 160378 160419 160114 160450 160429 160149 160137 160152 160153 160154 160138 160446 160368 160394 160412 160387 160432 160147 160433 160483 160335 160402 160356 160425 160148 160337 160460 160485 160443 160461 160370 160381 160508 160122 160407 160325 160494 160390 160507 160144 160487 160418 160007 160001 160363 160341 160139 160430 160482 160006 160462 160520 160505 160445 160322 160323 160382 160421 160474 160116 160428 160131 160318 160357 160369 160498 160413 160414 160128 160373 160509 160551 160327 160338 160477 160519 160141 160469
• FEI Number: 2240869
• 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 tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X-ray will not be possible. The issue occurs sporadically; however, it may occur during an on-going procedure.
• FDA Determined Cause: Component design/selection
• Action: Urgent Medical Device Correction notification letters dated 6/12/19 were sent to customers. In the event the issue occurs, the system cannot be operated normally as X-ray will not possible. Planned procedures may have to be terminated and performed on an alternative X-ray system. Siemens advises that an alternative system is available to continue treatment in case of occurrence. Siemens is implementing a corrective action to all potentially affected users of the Artis Zee and AXIOM Artis systems with generator A100 via Update Instruction AX038/18/S. The Siemens Service organization will modify the affected supply circuit and revise the wiring. This modification will bring the voltage back to the center of the tolerance range. 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.
• Quantity in Commerce: 117
• 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = OWB