—#51963

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;

FDA product code: KPS — System, Tomography, Computed, Emission
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K031825
Affected lot / code info: 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.

Why it was recalled

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.

Root cause (FDA determination)

Other

Action the firm took

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).

Recalling firm

Firm: Siemens Medical Solutions USA, Inc.
Address: 2501 Barrington Rd, Hoffman Estates, Illinois 60195-2061

Distribution

Distribution pattern: Worldwide-USA, Canada, France, Germany, Israel, The Netherlands and Portugal.

Timeline

Recall initiated: 2007-04-30
Posted by FDA: 2007-06-06
Terminated: 2009-01-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #51963. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.