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U.S. Department of Health and Human Services

Class 2 Device Recall ECAT EXACT HR 47

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  Class 2 Device Recall ECAT EXACT HR 47 see related information
Date Initiated by Firm July 23, 2007
Date Posted November 29, 2007
Recall Status1 Terminated 3 on September 11, 2009
Recall Number Z-0272-2008
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 47, Catalog No. 2956261, 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: 3600041-00-0001001, 3600050-000001, 3600050-00-0001001, 3600050-00-0001002, 3600050-00-0001004, 3600059-00-0001001, 3600059-00-0001002, 3600059-00-0001006
Recalling Firm/
Siemens Medical Solutions USA Inc
810 Innovation Dr
Knoxville TN 37932-2562
For Additional Information Contact Maria Ebio
Manufacturer Reason
for Recall
Incorrect Decay Correction Results - ECAT System's software versions 7.2.2 and 7.4 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
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 8 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.