FDAFDA · Food and drugs·Recall number Z-0787-2014
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" and PRIMUS" family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.
Published January 29, 2014 · Recall initiated: December 5, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Update to correct the possibility for patients or operators to have their fingers trapped or pinched between the table top and the bottom frame of the 550 TxT Treatment Table. Combined with this update instruction is a second complaint issue related to an incident in which a cable inside of the TxT" Treatment Table has been damaged due to contacting a moving part. The resulting short-circuit cau
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Distributor
- Worldwide Distribution: US (nationwide) and internationally to: Canada, Italy, P.R. China, Argentina, Pakistan, South Africa, Egypt, Iran, Vietnam, Indonesia, Brazil, Hungary, Bulgaria, India, Spain, Switzerland, Trinidad, Tobago, Italy, Algeria, Croatia, Turkey, Japan, Germany, Portugal, Poland, France, Sri Lanka, Russian Federation, France, Lebanon, Slovakia, Ukraine, Pakistan, and Korean Republic.
- Lot
- 550 TxT table - part number 07346534.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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