Class 2 Device Recall Innova 4100/4100IQ with InnovaIQ Table Option

• Date Initiated by Firm: June 03, 2010
• Date Posted: June 29, 2010
• Recall Status: Terminated on September 28, 2015
• Recall Number: Z-1923-2010
• Recall Event ID: 55552
• 510(K)Number: K023178 K031637 K050489 K033244 K042053
• Product Classification: Solid State X-Ray Imager - Product Code MQB
• Product: Innova 4100/4100IQ system with InnovaIQ Table Option; ; Indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally,; rotational imaging procedures.
• Code Information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and 00000000038WV0.
• Recalling Firm/ Manufacturer: Ge Healthcare, Llc; 3000 N Grandview Blvd; Waukesha WI 53188-1615
• For Additional Information Contact: 262-544-3894
• Manufacturer Reason for Recall: GE Healthcare has become aware of a potential loss of gantry and table motions affecting Innova 2100IQ, 3100, 3100IQ, 4100 and 4100IQ systems with InnovaIQ Table that may impact patient safety.
• FDA Determined Cause: Device Design
• Action: Consignees were sent on 6/3/10 a GE Healthcare "Urgent Medical device Correction" letter dated May 12, 2010. The letter was addressed to Hospital Administrators/ Risk Mangers, Managers of Radiology/Cardiology and Radiologists/ Cardiologists. The letter included the Safety Issue, Affected Product details, Safety Instructions, Product Correction and Contact Information. Customers are to contact a service representative immediately if they notice any cable damage.
• Quantity in Commerce: 69
• Distribution: Worldwide Distribution -- USA, including states of AL, AZ, CA, CO, FL, GA, IL, IN, KY, MA, MI, MS, MO, MT, NE, NJ, NY, NC, OH, OR, PA, TN, TX, VT, WA, WV, and WI and countries of UNITED KINGDOM, SWEDEN, REPUBLIC OF KOREA, NORWAY, NEW ZEALAND, ITALY, ISRAEL, IRELAND, INDIA, HONG KONG, GERMANY, FRANCE, FINLAND, CZECH REPUBLIC, and AUSTRALIA.
• 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 = MQB and Original Applicant = GE MEDICAL SYSTEMS; 510(K)s with Product Code = MQB and Original Applicant = GE MEDICAL SYSTEMS, INC.; 510(K)s with Product Code = MQB and Original Applicant = GE MEDICAL SYSTEMS, LLC