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U.S. Department of Health and Human Services

Class 2 Device Recall ECAT EXACT HR

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 Class 2 Device Recall ECAT EXACT HRsee related information
Date Initiated by FirmJuly 23, 2007
Date PostedNovember 29, 2007
Recall Status1 Terminated 3 on September 11, 2009
Recall NumberZ-0273-2008
Recall Event ID 45154
510(K)NumberK002584 K003541 K940478 K962797 
Product Classification Tomography Computed Emission System - Product Code KPS
ProductSiemens 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 ContactMaria 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 2
Software design
ActionSiemans 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 Commerce117 units
DistributionWorldwide 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 CycleTPLC 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) Database510(K)s with Product Code = KPS
510(K)s with Product Code = KPS
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