Class 2 Device Recall Artis Q, and Artis Q.zen ceiling systems

• Date Initiated by Firm: December 03, 2014
• Date Posted: January 14, 2015
• Recall Status: Terminated on April 06, 2015
• Recall Number: Z-0972-2015
• Recall Event ID: 70016
• 510(K)Number: K123529
• Product Classification: Interventional fluoroscopic x-ray system - Product Code OWB
• Product: Artis Q, and Artis Q.zen ceiling systems; model numbers: 10848281; 10848354: The Artis family is 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: model numbers: 10848281; 10848354
• Recalling Firm/ Manufacturer: Siemens Medical Solutions USA, Inc; 51 Valley Stream Pkwy; Malvern PA 19355-1406
• For Additional Information Contact: Customer Support; 610-219-6300
• Manufacturer Reason for Recall: Suboptimal routing of the cable may result in increased wear over time. Without additional measures, damage of a cable may result in limited functionality and in rare cases, failure of a system. An ongoing procedure could be terminated in rare cases.
• FDA Determined Cause: Device Design
• Action: Siemens sent an important customer safety information notice, dated December 3, 2014, to all affected customers. The letter identified the product, problem, and action to be taken. The following hardware modifications will be implemented with the corrective action AX042/14/S: 1. A modified cable outlet to provide additional space for the cabling. 2. A modified plastic cover at the cable outlet providing optimal cable guidance in the area of the arc. In general all systems will be checked for existing damage prior to the implementation of this action. For questions regarding this recall call 610-219-6300.
• Quantity in Commerce: 50
• 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 = OWB