Recall Z-2023-2011 ยท JAI Couch, Radiation Therapy, Powered
Siemens Medical Solutions USA, Inc
Siemens brand 550 TxT Patient Treatment Table, part number 7346534; Product is manufactured and distributed by Siemens AG, Medical Solutions, Roentgenstrasse 19-21, Kemnath, Germany 95478. The 550 TxT Treatment Table is to be used as an integral part of the Siemens linear accelerator systems to position the patient accurately according to the treatment plan for various radiation therapy treatment
| Date | Apr 19, 2011 (initiated Mar 31, 2010) |
| Status | Terminated |
| Reason | Potential for causing overheating of the power supply during treatment, and potential for unexpected table descent. |
| Root cause | Component design/selection |
| Action | Siemens issued a Customer Information letter dated March 21, 2010. There were two safety issues. There were two occurrences of smoke caused by an overheating of the power supply during patient treatment. Also, there had been a report of an unexpected lowering of the 550TxT table in patient rescue mode. With the released kit that accompanies this letter, Siemens has implemented a minor modification on the 550TxT to include an additional fuse within the power supply circuit to address the first issue described above. They also included an additional modification to address the lowering of |
| Quantity | 326 units |
| Distribution | Worldwide Distribution -- Including USA, states of NJ, WI, NY, and MA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K050422 | 550 TXT TREATMENT TABLE Siemens Medical Solutions USA, Inc., Mar 18, 2005 |