Z-2980-2011

Symbia Radiation Therapy Pallet. Siemens Medical Solutions USA, Inc. An accessory to the Symbia T Series...

Name: Z-2980-2011 Symbia Radiation Therapy Pallet. Siemens Medical Solutions USA, Inc. An accessory to the Symbia T Series...
Creator: Siemens Medical Solutions USA, Inc.
Published: 2011-06-22
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2011-06-22 / Terminated / root cause: design

FDA source

Siemens Medical Solutions USA, Inc. began a recall of Symbia Radiation Therapy Pallet. Siemens Medical Solutions USA, Inc. An accessory to the Symbia T Series Emission Computed Tomography System/X-Ray Computed... on 2011-06-22. The reason FDA records is "There a potential patient safety issue when using the Symbia Radiation Therapy Pallet. When a patient is not iso-centered before starting a scan with the Symbia T Series Systems and a non-circular orbit is selected, it...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2980-2011
Status: Terminated
Initiated: 2011-06-22
Posted: 2011-08-10
Terminated: 2012-11-27
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Symbia Radiation Therapy Pallet. Siemens Medical Solutions USA, Inc. An accessory to the Symbia T Series Emission Computed Tomography System/X-Ray Computed Tomography System.This specialty pallet is used for performing SPECT and/or SPECT/CT Scans on oncology patients with the goal of fusing the SPECT and/or SPECT/CT data with CT simulation data for planning radiation therapy. The pallet attaches to the patient beds carbon fiber pallet.
Product code: KPS System, Tomography, Computed, Emission
Reason for recall: There a potential patient safety issue when using the Symbia Radiation Therapy Pallet. When a patient is not iso-centered before starting a scan with the Symbia T Series Systems and a non-circular orbit is selected, it is possible that one of the detectors may come into contact with the patient.
Root cause tag: design
FDA root cause: Device Design
Action: Siemens Medical Solutions USA, Inc. sent an "Urgent Field Correction Recall" letter dated June 06, 2011 to all affected customers. The letter informs customers of the potential safety issue if the patient is not iso-centered before starting a scan and a non-circular orbit is selected and provided recommendations including ensure the patient is iso-centered before starting a scan. If the patient cannot be positioned at the iso-center of the RTP, instructions were provided. The customers are asked to complete the Mandatory Fax-Back Form acknowledging receipt and understanding of the letter. For questions or assistance contact Siemens Medical Solutions USA, Inc. at (800) 888-7436 (USA).
Quantity in commerce: 18 pallets
Distribution: Worldwide Distribution: Nationwide (USA) including the states of Florida and Texas; and the countries of Canada, China, Italy, Mexico, Poland, Portugal and Russia.
Product codes and lots: material number 10412621, serial numbers 1023, 1045, 1052, 1067, 1073, 1076, 1083, 1110, 1116, 1118, 1136, 1137, 1141, 1146, 1154, 1155, 1167 and 1241

Product code KPS

K082506Class IISymbia, Version 4.0Siemens Medical Solutions USA, Inc. / cleared 2008-11-21

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)