Class 2 Device Recall ARTISTE, ONCOR and PRIMUS Linear Accelerator systems

• Date Initiated by Firm: April 03, 2012
• Date Posted: May 03, 2012
• Recall Status: Terminated on March 14, 2013
• Recall Number: Z-1486-2012
• Recall Event ID: 61545
• 510(K)Number: K060226 K103606
• Product Classification: Accelerator, linear, medical - Product Code IYE
• Product: 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.
• Code Information: System IVK no. Component Component IVK Ser # ARTISTE MV system 8139789 550 TxT table 7346534 d1894 ONCOR Expression 7360717 550 TxT table 7346534 d1894 ONCOR Impression 5857912 550 TxT table 7346534 d1894 Plus ONCOR Impression 5857920 550 TxT table 7346534 d1894 ONCOR Avant Garde 5863472 550 TxT table 7346534 d1894 PRIMUS HI 4504200 550 TxT table 7346534 d1894 PRIMUS Mid-Energy 1940035 550 TxT table 7346534 d1894
• Recalling Firm/ Manufacturer: Siemens Medical Solutions USA, Inc; 4040 Nelson Ave; Concord CA 94520-1200
• For Additional Information Contact: Adrianna Azevedo; 925-602-8175
• Manufacturer 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.
• FDA Determined Cause: Software design
• 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.
• Quantity in Commerce: 624 active devices
• Distribution: 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, .
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = IYE