Z-2023-2011

Siemens brand 550 TxT Patient Treatment Table, part number 7346534; Product is manufactured and distributed...

Name: Z-2023-2011 Siemens brand 550 TxT Patient Treatment Table, part number 7346534; Product is manufactured and distributed...
Creator: Siemens Medical Solutions USA, Inc
Published: 2010-03-31
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2010-03-31 / Terminated / root cause: design

FDA source

Siemens Medical Solutions USA, Inc began a recall of Siemens brand 550 TxT Patient Treatment Table, part number 7346534; Product is manufactured and distributed by Siemens AG, Medical Solutions, Roentgenstrasse... on 2010-03-31. The reason FDA records is "Potential for causing overheating of the power supply during treatment, and potential for unexpected table descent". 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-2023-2011
Status: Terminated
Initiated: 2010-03-31
Posted: 2011-04-19
Terminated: 2012-03-01
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: 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 techniques.
Product code: JAI Couch, Radiation Therapy, Powered
Reason for recall: Potential for causing overheating of the power supply during treatment, and potential for unexpected table descent.
Root cause tag: design
FDA 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 the table by the integration of additional relays. As soon as the "move enable" button is released, the table brake will be enabled which is controlled by the implemented relays. No further action is required for the continued operations of the 550TxT table. Further questions regarding this recall please call (925) 246-8407
Quantity in commerce: 326 units
Distribution: Worldwide Distribution -- Including USA, states of NJ, WI, NY, and MA.
Product codes and lots: All units of Listing Number: R864406

Product code JAI

K050422Class II550 Txt Treatment TableSiemens Medical Solutions USA, Inc. / cleared 2005-03-18

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)