—#108690

Product

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.

FDA product code: KPS — System, Tomography, Computed, Emission
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K072567
Affected lot / code info: Material number 10275879, serial numbers 1028, 1034, 1062, 1098, 1106, 1134, 1138, 1205 and 1283.

Why it was recalled

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 (FDA determination)

Employee error

Action the firm took

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.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc.
Address: 2501 Barrington Rd, Hoffman Estates, Illinois 60195-2061

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2012-05-15
Posted by FDA: 2012-05-30
Terminated: 2016-12-23
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #108690. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.