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U.S. Department of Health and Human Services

Class 2 Device Recall c.cam

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 Class 2 Recall
c.cam
see related information
Date Posted June 06, 2007
Recall Status1 Terminated on January 09, 2009
Recall Number Z-0906-2007
Recall Event ID 37857
Premarket Notification
510(K) Number
K031825 
Product Classification System, Tomography, Computed, Emission - Product Code KPS
Product c.cam Gamma Camera, Model 9VIR1200; Siemens Medical Solutions USA, Inc., Molecular Imaging, 2501 N. Barrington Road, Hoffman Estates, IL 60195-5203; Made in Denmark;
Code Information Model 9VIR1200, serial numbers 1001 thru 1243, 1245 thru 1263, 1265 thru 1283, 1285 thru 1303, 1305 thru 1316, 1320, 1321, 1322, 1323, 1325 thru 1343, 1345 thru 1363, 1365 thru 1383, 1385 thru 1403, 1405 thru 1422, 1507, 1508, 1509.
Recalling Firm/
Manufacturer
Siemens Medical Solutions USA, Inc.
2501 Barrington Rd
Hoffman Estates, Illinois 60195-2061
For Additional Information Contact Mr. Ron Nolte
847-304-7516
Manufacturer Reason
for Recall
Chair Breakage: Under extreme load, the chair back of the c.cam emission computed tomography system may bend and eventually break. This could be caused by the accumulated stress from heavy patients seating or stretching themselves in the chair or simply from long time use.
FDA Determined
Cause 2
DESIGN: Device Design
Action Important Safety Notice letters dated 4/30/07 on Siemens letterhead were sent to the end users, informing them of the potential risk that the c.cam chair may bend or break under heavy load. They were told that a Siemens service representative will contact them within the next few days to arrange the repair of the chair at no cost to the end user. To ensure the chair does not become damaged, SIemens recommended that the c.cam not be used for patient scanning until the update has been performed on the chair. Any questions regarding the Important Safety Notice were directed to their service representative or Siemens' office at: 1-800-888-7436 (USA).
Quantity in Commerce 413 cameras
Distribution Worldwide-USA, Canada, France, Germany, Israel, The Netherlands and Portugal.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = KPS and Original Applicant = DANISH DIAGNOSTIC DEVELOPMENT A/S
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