Class 2 Device Recall GE Definium 8000

• Date Initiated by Firm: January 02, 2008
• Date Posted: September 25, 2008
• Recall Status: Terminated on December 10, 2011
• Recall Number: Z-1883-2008
• Recall Event ID: 49487
• 510(K)Number: K051967
• Product Classification: X-Ray System - Product Code KPR
• Product: GE Healthcare Definium 8000 Digital Radiographic System, model number 5135678. GE Healthcare, 3000 North Grandview, Waukesha, WI 53188 U.S.A. The intended use of this product is to generate tomographic images of human anatomy.
• Code Information: serial numbers: 0000000002772E, 00000001191M36, 00000001561M30, 00000001895M32, 00000002041M32, 00000002047M39, 00000002051M31, 00000002052M39, 00000002065M31, 00000002364M38, 00000002439M38, 00000002441M34, 00000002650M30, 00000002767EN2, 00000002771M34, 00000002965M32, 00000002968M36, 00000003468M36, 00000003505M35, 00000003506M33, 00000003806M37, 00000004101M32, 00000004105M33, 00000004199M36, 00000004442M30, 00000004547M36, 00000005052M36, 00000005487M34, 00000096383DP5, 00000096401DP5, 00000096986DP%, 00000097412DP1, 00000097656DP3, 00000097918DP7, 00000100740WK6, 00000114134VE0, 00000114148VE0, 00000114297VE5, 00000114452VE6, 00000TA41711-6, 00000TA41732-3, 00000TA41827-4, 00000TA41867-8, 00000TA41882-7, 00000TA41896¿4, 00000TA41972-3, 00000TA41984-4, 00000TA41984-6, 00000TA41995-7, 00000TA42004¿5, 00000TA42007-4, 00000TA42020-3, 00000TA42025¿4, 00000TA42184-1, 00000TA42274-8, 00000TA42869-6, 00001003925WK3, 00001003974WK1, 00001004022WK8, 00001004138WK2, 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• Recalling Firm/ Manufacturer: GE Healthcare; 3000 N Grandview Blvd; Waukesha WI 53188-1615
• For Additional Information Contact: 262-544-3894
• Manufacturer Reason for Recall: Not properly labeling the manual switch for disabling positive beam limitation (PBL) located on the overhead tube support user interface as required
• FDA Determined Cause: Radiation Control for Health and Safety Act
• Action: GE Field Engineer will visit each site to implement the correct label. Contact GE Healthcare at 1-262-544-3894 for assistance.
• Quantity in Commerce: 668 (419 US / 249 OUS)
• Distribution: AL, CA, CO, CT, DE, FL, GA, IA,, IL,, IN, KS, LA, MA, MD, MI, MN, MO, MT, NC, ND, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI,WV and Washington D.C. OUS to include: Australia, Austria, Belgium, China, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Guyana, Hong Kong, India, Ireland, Israel, Italy, Japan, Kuwait, Malta, Martinique (French), Netherlands, Norway, Palestine, Portugal, Romania, Saudi Arabia, South Korea, Spain, Sweden, Switzerland, Taiwan, United Arab Emirates, and Yugoslavia,
• 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 = KPR