Class 2 Device Recall ECAT EXACT HR

• Date Initiated by Firm: July 23, 2007
• Date Posted: November 29, 2007
• Recall Status: Terminated on September 11, 2009
• Recall Number: Z-0273-2008
• Recall Event ID: 45154
• 510(K)Number: K940478 K962797 K002584 K003541
• Product Classification: Tomography Computed Emission System - Product Code KPS
• Product: Siemens ECAT EXACT HR+, Catalog No. 3548083, PET/CT Scanner, Manufactured by Siemens Medical Solutions USA, Inc., 810 Innovation Drive, Knoxville, TN 37932 USA, TEL: 865-218-2534
• Code Information: Serial Numbers: 070-001012, 070-001021, 070-001022, 070-001024, 080-001014, 1001, 1005, 1009, 101007, 1011, 1026, 3600063-00-0001002, 3600063-00-0001004, 3600063-00-0001005, 3600063-00-0001007, 3600063-00-0001008, 3600070-00-0001001, 3600070-00-0001003, 3600070-00-0001006, 3600070-00-0001007, 3600070-00-0001008, 3600070-00-0001013, 3600070-00-0001015, 3600070-00-0001016, 3600070-00-0001017, 3600070-00-0001018, 3600070-00-0001019, 3600070-00-0001023, 3600070-01-0001001, 3600070-01-001002, 3600070-01-001004, 3600070-01-001006, 3600070-01-001008, 3600070-01-001011, 3600070-01-001017, 3600070-01-001020, 3600070-01-001027, 3600070-01-001037, 3600070-01-001043, 3600070-01-001063, 3600076-00-0001001, 3600076-00-0001002, 3600076-00-0001003, 3600080-00-0001002, 3600080-00-0001003, 3600080-00-0001004, 3600080-00-0001006, 3600080-00-0001007, 3600080-00-0001008, 3600080-00-0001009, 3600080-00-0001010, 3600080-00-0001011, 3600080-00-0001012, 3600080-00-0001013, 3600080-00-0001016, 3600086-00-0001002, 3600086-00-0001003, 3600086-00-0001004, 3600089-00-0001002, 3600089-00-0001003, 3600089-00-0001004, 3600089-00-0001005, 3600089-00-0001006, 3600089-00-0001007, 3600089-00-0001008, 3600089-00-0001010, 3600089-00-0001011, 3600089-00-0001012, 3600089-00-0001013, 3600089-00-0001014, 3600089-00-0001017, 3600089-00-0001018, 3600089-00-0001019, 3600089-00-0001021, 3600089-00-0001022, 3600098-00-0101002, 3600098-00-0101003, 3600098-00-0101004, 3600098-00-0101005, 3600098-00-0101006, 3600098-00-0101008, 3600098-00-0101009, 3600098-00-0101010, 3600098-00-0101012, 3600098-00-0101013, 3600098-00-0101015, 3600098-00-0101016, 3600098-00-0101017, 3600098-00-0101018, 3600098-00-0101019, 3600098-00-0101020, 3600098-00-0101021, 3600098-00-0101022, 3600098-00-0101023, 3600098-00-0101024, 3600098-00-0101025, 3600098-00-0101026, 3600098-00-0101027, 3600098-00-0101030, 3600098-00-0201028, 3600098-00-0201029, 3600098-00-0201031, 3600098-00-0201032, 3600098-00-0201033, 3600098-00-0201034, 3600098-00-0201035, 3600098-00-0201036, 3600098-00-0201037, 3600098-00-0201038, 3600098-00-0201039, 3600098-00-0301040, 3600098-00-0401044, 3800098-00-0201034, 401045, 9501006, 9601002, 9801029
• Recalling Firm/ Manufacturer: Siemens Medical Solutions USA Inc; 810 Innovation Dr; Knoxville TN 37932-2562
• For Additional Information Contact: Maria Ebio; 865-218-2534
• Manufacturer Reason for Recall: Incorrect Data Results - ECAT System's software versions 7.2.2 and 7.4 may calculate the decay correction for emission data incorrectly while performing whole-body studies with all transmissions followed by all emissions.
• FDA Determined Cause: Software design
• Action: Siemans sent an Urgent Device Correction letter, dated June 15, 2007, to all affected consignees informing the user of the problem and requesting that they discontinue the practice of running all transmissions followed by all emissions until a corrective software patch is installed. The corrective software patch is expected to be installed by October 2007.
• Quantity in Commerce: 117 units
• Distribution: Worldwide Distribution - USA and Countries of Argentina, Austria, Belgium, Brazil, Canada, Switzerland, Chile, China, Czech Republic, Germany, Denmark, Spain, Finland, France, Great Britain, Italy, Japan, South Korea, Netherlands, Norway, Saudi Arabia, Sweden, Slovak Republic, Turkey, and Taiwan.
• 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 = KPS and Original Applicant = CAO GROUP, INC.; 510(K)s with Product Code = KPS and Original Applicant = CTI PET SYSTEMS, INC.