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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm March 04, 2003
Date Posted March 21, 2003
Recall Status1 Terminated 3 on February 07, 2006
Recall Number Z-0674-03
Recall Event ID 25710
510(K)Number K913637  K920624  K940478  K962797  K002584  
Product Classification System, Tomography, Computed, Emission - Product Code KPS
Product ECAT Software Versions V7.1.1b, V7.2, V7.2.1, and V7.2.2 used in the following PET (Positron Emission Tomography) systems:

¿ Siemens Models: ECAT EXACT, ECAT EXACT HR, ECAT EXACT HR+, ECAT ART, ECAT EMERGE and ECAT ACCEL

¿ CTI Models: ECAT EXACT, ECAT EXACT HR+, ECAT ART, ECAT EMERGE, ECAT ACCEL, REVEAL QS and REVEAL XL

¿ Marconi Models: Magellan

¿ Hitachi Models: Sceptre and Sceptre XL
Code Information All serial numbers of above indicated scanner models using ECAT System Software Versions V7.1.1b, V7.2, V7.2.1 and V7.2.2
Recalling Firm/
Manufacturer		 Cti Pet Systems Inc
810 Innovation Drive
Knoxville TN 37932-2571
For Additional Information Contact Brad Herrington
865-218-2361
Manufacturer Reason
for Recall		 Incorrect patient information is displayed in the reconstructed images of a whole body patient scan.
FDA Determined
Cause 2		 Other
Action Written notification was sent via letter with corrective software beginning on March 4 to the end users.
Quantity in Commerce 444
Distribution Nationwide and the following foreign countries: Portugal, Japan Italy, belium, Taiwan, UK, Germany Canada Switzerland Netherlands, Austria, France, Turkey, Spain, Sweden, Korea, Saudi Arabia, Russia, PROC (China), Czech Republic, Denmark, Mexico, Slovakia, and Chile
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 = CTI PET SYSTEMS, INC.
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