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Terminated

Siemens-branded linear accelerator with a 550 TxT Treatment Table with a serial number <_ 1894. Siemens brand ARTISTE, ONCOR and PRIMUS Linear Accelerator systems include the 550 TxT" Treatment Table. Manufactured by: SIEMENS AG, MEDICAL SOLUTIONS Roentgenstrasse 19-21 Kemnath, GERMANY 95478. Product Usage: 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.

FDA Recall Z-1486-2012 · Posted 2012-05-03

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeIYE
Date Initiated2012-04-03
Date Terminated2013-03-14
Product Quantity624 active devices

Reason for Recall

SIEMENS has received reports where a dropping down of the 550 TxT" Treatment Table was observed while the table was being moved downwards during operation by means of the hand control.

Firm Action

Siemens sent Customer Information letters to all affected customers beginning April 3, 2012 via Siemens Field Service Engineers. The letter identified the affected product, what is the issue and what has Siemens done to address this issue. The letter included an Update Instructions TH006/12/S - TxT Table Software Update VD00A. SIEMENS has arranged for a modification of the affected system. A SIEMENS Service Representative will ensure that the new software version VD00A is installed on affected system. The letter instructs customer to please include this Customer Information in their Digital Linear Accelerator System Owner Manual chapter Safety Advisory Letters where it should remain.

Root Cause

Software design

Distribution Pattern

Worldwide Distribution - USA (nationwide) including P.R and the countries of: Africa, Angola, Argentina, Australia, Austria, Belgium, Bosnia, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Egypt, France, Germany, Greece, Hungary, India, Indonesia, Italy, Japan, Kuwait, Lebanon, Malaysia, Mexico, Myanmar, Netherlands, New Zealand, Norway, Pakistan, Philippines, Poland, Portugal, Republic of Korea, Russian Federation, Saudi Arabia, Serbia, South Thailand, Sri Lanka, Spain, Switzerland, Trinidad, Tobago, Turkey, Ukraine and United Kingdom, .

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K103606ARTISTE SOLUTION WITH SYS_VB50 UPDATESiemens Medical Solutions USA, Inc. · 2011-04-15K060226ONCOR EXPRESSIONSiemens Medical Solutions USA, Inc. · 2006-03-15

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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