Class 2 Device Recall GE Healthcare Innova 4100IQ

• Date Initiated by Firm: September 04, 2014
• Date Posted: December 16, 2014
• Recall Status: Terminated on January 21, 2015
• Recall Number: Z-0453-2015
• Recall Event ID: 69286
• 510(K)Number: K052412
• Product Classification: Interventional fluoroscopic x-ray system - Product Code OWB
• Product: Innova 4100IQ Indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and Interventional procedures and optionally, rotational imaging procedure.
• Code Information: Mfg Lot or Serial # System ID 00000583668BU9 610983INNOVA3 00000643314BU8 082406090024 00000644609BU0 082406210011 00000645290BU8 082406110006 00000645780BU8 082406040032 00000648200BU4 082406070014
• Recalling Firm/ Manufacturer: GE Healthcare, LLC; 3000 N Grandview Blvd; Waukesha WI 53188-1615
• For Additional Information Contact: 800-437-1171
• Manufacturer Reason for Recall: Loss of imaging - affected devices may experience a loss of real-time interventional imaging and/or gantry motion due to the Electromagnetic (EM) sensitivity of the grid detection mechanism.
• FDA Determined Cause: Device Design
• Action: Consignees were sent on 9/4/2014 a GE Healthcare "Urgent Medical Device Correction" letter GEHC Ref#12218 dated September 4, 2014. The letter was addressed to Director of Biomedical Engineering, Director of Radiology and Chief of Cardiology. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction, and Contact Information. Customers are to perform a system functional check as instructed in the letter. If the check fails, they should contact their local GE Healthcare Service Representative. GE Healthcare will correct all systems at no cost to the customer, and a representative will contact customers to arrange for the correction. For questions they can call US 800-437-1171. For other countries they can call their local GE Healthcare Service Representative.
• Quantity in Commerce: 6 (1 US, 5 OUS)
• Distribution: Worldwide Distribution -- US, including the states of CA, CO, FL, MO, PA; and, the countries of BELGIUM, CHINA, COLOMBIA, FRANCE, GREECE, MEXICO, and RUSSIA.
• 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