The Recall Desk
HighFDA (Devices)·Z-0787-2014·Announced 2014-01-29

Siemens Linac Treatment Table Recall for Finger Pinch and Cable Damage

Siemens is recalling 305 linear accelerator treatment tables due to risks of finger pinching and cable short-circuits.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (pinching and electrical short-circuit) where specific injuries or illnesses have not been reported in the source text, fitting the High severity criteria.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling 305 active PRIMUS, ONCOR, and ARTISTE linear accelerator systems equipped with the 550 TxT Treatment Table. The affected table tops include models TT-A, TT-D, TT-M, and TT-S. These devices are intended to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.

The recall is issued to address two specific safety issues. First, there is a possibility that patients or operators may have their fingers trapped or pinched between the table top and the bottom frame. Second, an incident occurred where a cable inside the treatment table was damaged by contacting a moving part, resulting in a short-circuit.

The affected devices were distributed worldwide, including nationwide in the United States and in numerous international locations such as Canada, Italy, China, and Germany. Users should contact Siemens Medical Solutions USA, Inc. for further instructions regarding the update and corrective actions.

The recalled product

Product
PRIMUS, ONCOR, ARTISTE Linac systems with component 550 TxT Treatment Table. TT-A, TT-D, TT-M or TT-S Table tops. Manufactured by: SIEMENS AG, MEDICAL SOLUTIONS Roentgenstrasse 19-21 Kemnath, GERMANY 95478 The intended use of the SIEMENS branded, ARTISTE", ONCOR" a
Affected units
305

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • 550 TxT table - part number 07346534.

Distribution

Distributed nationwide across the United States.

Same manufacturer · Siemens Medical Solutions USA, Inc

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