Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Biograph PET/CT, dist by Siemens Medical Solutions & Reveal PET/CT, dist CTI Molecular

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Biograph PET/CT, dist by Siemens Medical Solutions & Reveal PET/CT, dist CTI Molecular see related information
Date Initiated by Firm October 02, 2003
Date Posted November 13, 2003
Recall Status1 Terminated 3 on February 07, 2006
Recall Number Z-0106-04
Recall Event ID 27358
510(K)Number K002715  K013504  
Product Classification System, Tomography, Computed, Emission - Product Code KPS
Product Siemens Models: BIOGRAPH, BIOGRAPH LSO and CTI Models: REVEAL HD, REVEAL RT
Code Information All CPS manufactured PET/CT systems distributed between October 31, 2000 and June 24, 2003.
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		 CPS has found that in some instances, when the CT E-Stop is activated, a malfunction may occur where the PHS controller may not shut down and stop bed motion.
FDA Determined
Cause 2		 Other
Action Written notification was sent out beginning 10/02/2003 to distributors and end users to advise them of the problem.
Quantity in Commerce 73
Distribution Nationwide International: Japan, Germany, Brazil, Spain, China, Russia, Austrailia, Hong Kong, Singapore, Poland France, Korea, Greece, UK and Austria
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.
-
-