Class 2 Device Recall Siemens Artis zee Ceiling Systems

• Date Initiated by Firm: December 16, 2013
• Date Posted: February 24, 2014
• Recall Status: Terminated on March 09, 2015
• Recall Number: Z-1080-2014
• Recall Event ID: 67175
• 510(K)Number: K073290
• Product Classification: System, x-ray, angiographic - Product Code IZI
• Product: Siemens Artis zee Ceiling Systems. Angiographic x-ray system.
• Code Information: Artis zee Ceiling systems serial numbers from 146352 to 147617
• 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: During the lifetime of Artis zee Ceiling systems, there is an increased wear due to potential sub-optimal cable guidance that can lead to cable damage.
• FDA Determined Cause: Device Design
• Action: In December 2013, a recall notification letter was sent to Users.
• Quantity in Commerce: 284
• Distribution: 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