Symbia Radiation Therapy Pallet. Siemens Medical Solutions USA, Inc. An accessory to the Symbia T Series Emission Comput
FDA device recall Z-2980-2011 · posted 2011-08-10 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc.
- 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.
- 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).
- Root cause
- Device Design
- Status
- Terminated
- Product code
- KPS
- Quantity affected
- 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.
- Date initiated
- 2011-06-22
- Date posted
- 2011-08-10
- Date terminated
- 2012-11-27
- Location
- Hoffman Estates, IL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SYMBIA, VERSION 4.0 (K082506) | Siemens Medical Solutions USA, Inc. | 2008-11-21 |