Class 2 Device Recall ARTISTE or ONCOR Linear Accelerators in combination with 160MLC

• Date Initiated by Firm: April 15, 2011
• Date Posted: June 02, 2011
• Recall Status: Terminated on March 16, 2012
• Recall Number: Z-2404-2011
• Recall Event ID: 58637
• 510(K)Number: K072486 K092145
• Product Classification: Accelerator, linear, medical - Product Code IYE
• Product: ARTISTE or ONCOR Linear Accelerators in combination with 160MLC (Multi Leaf Collimator). Linear Accelerators that may be affected are:; ARTISTE MV System;; ONCOR Avant Garde; ONCOR Impression; ONCOR Impression Plus; ONCOR Expression.; Manufactured by Siemens AG, Medical Solutions, Kemnath, Germany;; Registered by Siemens Medical Solutions, Concord, CA.; ; ARTISTE and ONCOR family of Linear Accelerators are used to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.
• Code Information: Product Model Number ARTISTE MV System 8139789 ONCOR Avant Garde 5863472 ONCOR Impression 5857920 ONCOR Impression Plus 5857912 ONCOR Expression 7360204 and 7360717
• Recalling Firm/ Manufacturer: Siemens Medical Solutions USA, Inc; 4040 Nelson Ave; Concord CA 94520-1200
• For Additional Information Contact: Christine Dunbar; 925-602-8157
• Manufacturer Reason for Recall: Siemens became aware of a potential safety risk related to the behavior of the 160 MLC when using the "Motion Stop" button followed by "Reset" several times during the treatment of one beam or one segment.
• FDA Determined Cause: Other
• Action: Siemens sent a Consumer Safety Advisory and Urgent Medical Device Correction letter to all affected customers beginning on April 15, 2011. The letter identified the product, the problem, and the action to be taken by the customer. Updated instructions for using the Motion Stop button with the 160-MLC were provided with the letter. Customers were requested to use the Motion Stop button and the corresponding reset procedure only when required. In the unlikely event that the Motion Stop button needs to be used repeatedly during treatment of the same beam or segment, customers were advised to perform an "in session resumption of the beam by selecting 'abort' at the syngo RT Therapist and then re-selecting the beam again for the remaining delivery. In this case, the beam will be re-loaded with the originally prescribed leaf positions. Please consider the already delivered dose for resumption. Customers were asked to include the Customer Advisory Notice in their LINAC System Owner Manual in chapter 'Safety Advisory Letters' where it should remain until the measures defined above were performed. Customers were asked to inform all affected personnel immediately.
• Quantity in Commerce: 221 active devices
• Distribution: Worldwide Distribution - USA including CA, DE, FL, IL, KY, LA, MA, MI, NE, NJ, NY, OH, PA, SD, TN, UT, WI, and WV.
• 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 and Original Applicant = HEMCON MEDICAL TECHNOLOGIES, INC.; 510(K)s with Product Code = IYE and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.