Recall Z-1686-2012 ยท KPS System, Tomography, Computed, Emission
Siemens Medical Solutions USA, Inc.
Symbia E Series SPECT System; Single-Photon Emission Computed Tomography. The Siemens Symbia E system is a high performance dual detector variable angle system with flexible patient positioning for planar imaging, whole-body scans, and SPECT studies.
| Date | May 30, 2012 (initiated May 15, 2012) |
| Status | Terminated |
| Reason | Siemens has identified a potential patient safety issue for e.cam and Symbia E camera systems that have had the radial drive motor assembly replaced during a Service action. There is a remote chance that during the motor replacement the radial drive gear may have been replaced incorrectly. If the gear is installed incorrectly the mechanical brake may not engage creating a patient hazard if the sys |
| Root cause | Employee error |
| Action | On May 15, 2012, Siemens Medical Solutions USA, Inc. sent an "Urgent Field Correction Recall" letter dated April 11, 2012 to all affected customers. The letters informed customers of the potential patient safety issue for e.cam and Symbia E camera systems that have had the radial drive motor assembly replaced during a Service action. Customers were informed that a Siemens Service Engineer will be inspecting the radial drive gear on their camera system to ensure it is functioning correctly. For questions or assistance they were instructed to contact Siemens Medical Solutions USA, Inc. at 800- |
| Quantity | 9 units |
| Distribution | Worldwide Distribution, US (Nationwide) and the countries of Australia, Belgium, Canada, China, France, Germany, Italy, Japan, Republic of Korea, Mexico, Netherlands, Portugal, Spain, Taiwan and the United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K072567 | SYMBIA-E, MODEL 10275879 Siemens Medical Solutions USA, Inc., Oct 30, 2007 |