Class 2 Device Recall Innova 4100

• Date Initiated by Firm: July 31, 2009
• Date Posted: September 24, 2009
• Recall Status: Terminated on May 15, 2012
• Recall Number: Z-2242-2009
• Recall Event ID: 52703
• 510(K)Number: K042053
• Product Classification: Solid state x-ray imager (flat panel/digital imager) - Product Code MQB
• Product: Innova¿ 4100/4100IQ GE Innova 4100 / 4100 IQ. , GE Healthcare, Waukesha, WI 53188 (The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector).; ; The Innova¿ systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational imaging procedures. They are also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic and interventional procedures. They are intended to replace fluoroscopic images obtained through image intensifier technology. Those devices are not intended for mammography applications.
• Code Information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and 00000428165BU5.
• Recalling Firm/ Manufacturer: GE Medical Systems, LLC; 3000 N Grandview Blvd; Waukesha WI 53188-1615
• For Additional Information Contact: 262-544-3894
• Manufacturer Reason for Recall: GE Healthcare has recently became aware of a potential power supply failure with the Innova¿ 2000, 3100 and 4100 systems that may impact patient safety. A potential power supply failure inside the GE equipment cabinet could occur with no advance warning and thereby prevent x-ray generation and image processing. Should this occur, the system cannot be restarted.
• FDA Determined Cause: Component design/selection
• Action: Consignees were sent a GE Healthcare "Urgent Medical Device Correction" letter dated June 25, 2009. The letter was addressed to Hospital Administrators/Risk Managers, Managers of Radiology/Cardiology or Radiologists/Cardiologists. The letter described the Safety Issue, Affected Product Details, Safety Instructions, Product Correction and Contact Information. GE Healthcare will correct all affected systems by replacing the power supply located in the GE equipment cabinet. A GE Healthcare service representative will contact you to arrange for this correction. Direct questions about the recall to the firm's Call Center by calling: 1-800-437 -1171, option 4 (United States) or 0120 - 055 - 919 (Japan). For other countries, please contact your local GE Healthcare field service Representative if you have any questions or concerns regarding the notification.
• Quantity in Commerce: 147
• Distribution: Worldwide Distribution -- US (states of AL, AZ, AR, CA, CO, CT, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA., MI, MN, MO, NE, NV, NH, NJ, NY, NC, OH, OK , OR, PA, PR, RI, SC, TN, TX, UT VA, WA, WI and WV), TUNISIA, THAILAND , TAIWAN, SYRIAN ARAB REPUBLIC, SWEDEN SPAIN, SOUTH AFRICA SAUDI ARABIA, RUSSIAN FEDERATION , POLAND, NORWAY, NEW ZEALAND, NETHERLANDS, MOROCCO, MEXICO, MARTINIQUE, MACAU, LEBANON, KUWAIT, REPUBLIC OF KOREA, JAPAN, ITALY, ISRAEL, IRAN, INDONESIA, INDIA, GREECE, GERMANY, FRANCE , CHINA, CANADA, BULGARIA, BRAZIL BELGIUM, BELARUS 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, INC.