Class 2 Device Recall Siemens Artis Zee Family

• Date Initiated by Firm: February 07, 2014
• Date Posted: March 31, 2014
• Recall Status: Terminated on March 16, 2015
• Recall Number: Z-1309-2014
• Recall Event ID: 67558
• 510(K)Number: K073290
• Product Classification: Angiographic x-ray system - Product Code IZI
• Product: Artis Zee Angiographic x-ray systems.
• Code Information: Model numbers: 10094135, 10094137, 10094139, 10094141, 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: An inappropriate cable connection was assembled for certain Artis zee systems. which may cause a system failure and possibly lead to a restricted maneuverability of the gantry system.
• FDA Determined Cause: Device Design
• Action: A recall notification letter dated February 7, 2014, was sent to End Users.
• Quantity in Commerce: 9
• Distribution: MN, WI, PA, MI, AL, OH, NC, AR, and NJ.
• 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.