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.
- Recall Initiated
- June 22, 2011
- Posted
- August 10, 2011
- Terminated
- November 27, 2012
- Recall Number
- Z-2980-2011
- Quantity
- 18 pallets
- Firm Location
- Hoffman Estates, IL
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.
Distribution
Worldwide Distribution: Nationwide (USA) including the states of Florida and Texas; and the countries of Canada, China, Italy, Mexico, Poland, Portugal and Russia.
Lot / Code Info
material number 10412621, serial numbers 1023, 1045, 1052, 1067, 1073, 1076, 1083, 1110, 1116, 1118, 1136, 1137, 1141, 1146, 1154, 1155, 1167 and 1241
Root Cause
Device Design
Action Taken
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).