c.cam Gamma Camera, Model 9VIR1200; Siemens Medical Solutions USA, Inc., Molecular Imaging, 2501 N...
Siemens Medical Solutions USA, Inc. began a recall of c.cam Gamma Camera, Model 9VIR1200; Siemens Medical Solutions USA, Inc., Molecular Imaging, 2501 N. Barrington Road, Hoffman Estates, IL 60195-5203; Made in... on . The reason FDA records is "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...". As of , the recall status on record is Terminated.
Recall record
- Recall number
- Z-0906-2007
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Siemens Medical Solutions USA, Inc.
- 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;
- Product code
- KPS System, Tomography, Computed, Emission
- 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 root cause
- Other
- 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.
- Product codes and lots
- 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.
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