Recall Z-0304-2008 ยท KPS System, Tomography, Computed, Emission
Siemens Medical Solutions USA, Inc.
c.cam Gamma Camera, Model No: 9VIR1200; Tomography System (Emission Computed); Siemens Medical Solutions USA, Inc., Molecular Imaging, 2501 N. Barrington Road, Hoffman Estates, IL 60195-5203; Made in Denmark
| Date | Dec 19, 2007 (initiated Sep 17, 2007) |
| Status | Terminated |
| Reason | Unintended Motion: A hardware fault in the c.cam system can cause the system to experience unintended motion, thereby causing a collision hazard. |
| Root cause | Software design |
| Action | Urgent Field Correction Recall letters dated 9/11/07, on Siemens letter head were sent to the end users via U.S. certified mail, informing them of the potential risk of unintended motion of the detector head resulting in a collision hazard. The end users were warned not to press any of the detection motion buttons while simultaneously holding the collision over ride button on the c.cam hand controller, and were provided steps to take if the system stops during an acquisition and displays the Collision Error message. They were told that a Siemens service representative will contact them withi |
| Quantity | 486 units |
| Distribution | Worldwide: USA including Puerto Rico and Brazil, Canada, France, Germany, Great Britain, 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 |