Class 2 Device Recall Artis Q

• Date Initiated by Firm: April 09, 2019
• Create Date: May 15, 2019
• Recall Status: Terminated on April 23, 2020
• Recall Number: Z-1341-2019
• Recall Event ID: 82730
• 510(K)Number: K123529
• Product Classification: System, x-ray, angiographic - Product Code IZI
• Product: Artis Q (material 10848280, 10848281, 10848282) - Product Usage: AXIOM Artis zee and Q/ Q.zen is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the AXIOM Artis zee and Q/ Q.zen family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. AXIOM Artis zee and Q/ Q.zen can also support the acquisition of position triggered imaging for spatial data synthesis.
• Code Information: Serial Number 103302 103279 103285 103286 103277 103295 103310 103293 109569 109502 109592 109523 109583 109512 109496 109542 109589 109552 109598 109500 109504 109505 109526 109565 109536 109520 109501 109507 109567 109541 109515 109551 109518 109538 109531 109532 109543 109503 109497 109527 109560 109564 109558 109524 109525 109591 121471 121467 121501 121445 121459 121490 121461 121491 121455 121504 121457 121460 121493 121487 121472 121478 121479 121470 121485 121486 121462 121468 121505 121506 121502
• Recalling Firm/ Manufacturer: Siemens Medical Solutions USA, Inc; 40 Liberty Blvd; Malvern PA 19355-1418
• For Additional Information Contact: 610-219-4834
• Manufacturer Reason for Recall: In affected Artis systems the movement of the floating tabletop may be blocked after a collision sensor has been activated during system movement.
• FDA Determined Cause: Software design
• Action: On April 9, 2019, the firm distributed Urgent Medical Device Correction letters to affected customers. Customers were informed that ARTIS systems equipped with certain motor control units may encounter with hardware failure, and planned procedures may need to be terminated and performed on an alternative x-ray system. The firm stated their service organization would contact customers shortly to arrange a date to perform a software update to correct the issue. For an earlier appointment or if you have any questions, you may contact the firm at 1-800-888-7436. Customers were asked to promptly notify and instruct all staff at the organization who need to be aware of the notice. Additionally, if you further distributed the product, please identify your customers and notify them at once of this recall.
• Quantity in Commerce: 459 (116 US)
• Distribution: Worldwide distribution - US Nationwide distribution in the states of AL,AR, AZ, CA, FL, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NV, NY, OH, OK, OR, PA, RI, SC, SD, TX, UT, VA , WA WI and WV. and Foreign countries.
• 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 = IZI and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.