FDA Device

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.

Hazard

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

What You Should Do

Remedy

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 800-888-7436.

Products

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 pl
Brand
Siemens Medical Solutions USA, Inc.
UPC
Material number 10275879, serial numbers 1028, 1034, 1062, 1098, 1106, 1134, 1138, 1205 and 1283.

Units Affected

9 units