Recall Z-0623-03 ยท KPS System, Tomography, Computed, Emission
Siemens Medical Solutions USA, Inc.
e.cam Emission Imaging Computed Tomography Systems used for all common nuclear medicine procedures; Siemens Medical Systems, Inc., Nuclear Medicine Group, Hoffman Estates, IL 60195-5203
| Date | Mar 6, 2003 (initiated Feb 10, 2003) |
| Status | Terminated |
| Reason | Unexpected release of the radial and rotate brakes in the case of multiple simultaneous fault conditions. |
| Root cause | Other |
| Action | Siemens sent Customer Advisory letters dated 2/10/03 to all e.cam customers. The accounts were informed of the problem with unexpected camera movement when multiple fault cocnditions are presnet, causing the brake system to release and the roation of the detector assemblies, and were advised to use the emergency stop at any indication of improper camera movement. The customers were advised that they would be contacted by their Siemens Customer Service Representative to schedule a firmware upgrade that will prevent the occurrence of unintended release of the radial and rotate brakes. The upg |
| Quantity | 1927 units |
| Distribution | Nationwide, United Arab Emirates, Argentina, Austria, Australia, Bosnia, Barbados, Bangladesh, Belgium, Bolivia, Brazil, Camaroon, Canada, Chile, China, Colombia, Republic of Congo, Czech Republic, Denmark, Dominican Republic, El Salvador, Equador, Egypt, France, Finland, Germany, Great Britain, Ge |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K952109 | IP500 NUCLEAR GAMMA CAMERA SYSTEM Siemens Medical Solutions USA, Inc., Aug 23, 1995 |