Class 2 Device Recall Innova 3100

• Date Initiated by Firm: July 31, 2009
• Date Posted: September 24, 2009
• Recall Status: Terminated on May 15, 2012
• Recall Number: Z-2241-2009
• Recall Event ID: 52703
• 510(K)Number: K042053 K031637
• Product Classification: Solid state x-ray imager (flat panel/digital imager) - Product Code MQB
• Product: Innova¿ 3100/3100IQ GE Innova 3100 / 3100 IQ, Cardiovascular Imaging System, 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: 00000423793BU9 00000424103BU0 00000427535BU0 00000429845BU1 00000430039BU8 and 00000410867BU6.
• 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: 6
• 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; 510(K)s with Product Code = MQB and Original Applicant = GE MEDICAL SYSTEMS, INC.