Recall Z-0906-2007 ยท KPS System, Tomography, Computed, Emission
Siemens Medical Solutions USA, Inc.
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;
| Date | Jun 6, 2007 (initiated Apr 30, 2007) |
| Status | Terminated |
| Reason | 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 | 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 re |
| Quantity | 413 cameras |
| Distribution | Worldwide-USA, Canada, France, Germany, Israel, The Netherlands and Portugal. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031825 | C.CAM Danish Diagnostic Development A/S, Jun 20, 2003 |