Z-1686-2012

Symbia E Series SPECT System; Single-Photon Emission Computed Tomography. The Siemens Symbia E system is a...

Name: Z-1686-2012 Symbia E Series SPECT System; Single-Photon Emission Computed Tomography. The Siemens Symbia E system is a...
Creator: Siemens Medical Solutions USA, Inc.
Published: 2012-05-15
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2012-05-15 / Terminated / root cause: manufacturing process

FDA source

Siemens Medical Solutions USA, Inc. began a recall of Symbia E Series SPECT System; Single-Photon Emission Computed Tomography. The Siemens Symbia E system is a high performance dual detector variable angle system... on 2012-05-15. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1686-2012
Status: Terminated
Initiated: 2012-05-15
Posted: 2012-05-30
Terminated: 2016-12-23
Recalling firm: Siemens Medical Solutions USA, Inc.
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.
Product code: KPS System, Tomography, Computed, Emission
Reason for recall: 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 tag: manufacturing process
FDA 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 800-888-7436.
Quantity in commerce: 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.
Product codes and lots: Material number 10275879, serial numbers 1028, 1034, 1062, 1098, 1106, 1134, 1138, 1205 and 1283.

Product code KPS

K072567Class IISymbia-E, Model 10275879Siemens Medical Solutions USA, Inc. / cleared 2007-10-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)