Class 2 Device Recall Siemens AXIOM Artis or Artis zee system

• Date Initiated by Firm: June 05, 2014
• Date Posted: September 24, 2014
• Recall Status: Terminated on April 06, 2015
• Recall Number: Z-2587-2014
• Recall Event ID: 68618
• 510(K)Number: K010721 K073290
• Product Classification: System, x-ray, angiographic - Product Code IZI
• Product: AXIOM Artis or Artis zee system Product Usage: Axiom Artis and Artis zee / zeego are 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 include cardiac angiography, neuro angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures
• Code Information: material number 3771750, model numbers: 5904441, 5904466, 7008605, 7412807, 7413078, 7555357, 7555365, 7555373, 7727717, 7728392, 10094135, 10094137, 10094139, 10094141, 10094142, 10094143, and 10280959
• Recalling Firm/ Manufacturer: Siemens Medical Solutions USA, Inc; 51 Valley Stream Pkwy; Malvern PA 19355
• For Additional Information Contact: Customer Support; 610-219-6300
• Manufacturer Reason for Recall: There is a potential problem with the AXIOM Artis or Artis zee system in connection with the hand switch operated at the patient table which may result in uncontrolled release of an x-ray image.
• FDA Determined Cause: Device Design
• Action: Siemens sent an Important Safety Information letter dated June 5, 2014, to affected customers. The letter described the affected product, problem, and actions to be taken. Customers were instructed to observe this safety notice and comply with the corresponding measures until the update has been fully completed.
• Quantity in Commerce: 1067
• 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 = IZI; 510(K)s with Product Code = IZI