Class 2 Device Recall ARTISTE , ONCOR and PRIMUS accelerators

• Date Initiated by Firm: March 31, 2011
• Date Posted: May 19, 2011
• Recall Status: Terminated on March 30, 2012
• Recall Number: Z-2216-2011
• Recall Event ID: 58534
• 510(K)Number: K072486 K060226 K993425
• Product Classification: Accelerator, linear, medical - Product Code IYE
• Product: ARTISTE , ONCOR and PRIMUS accelerators that utilize the RT Therapist v4.2 system in combination with syngo RT Oncologist 4.2.; The ONCOR and PRIMUS may be updated to utilize the RT Therapist v4.2 software. The RT Oncologist v4.2 is currently only on Non-US systems. ; Distributed by Siemens Healthcare, Concord, CA 94520; ; Intended use: Radiation therapy
• Code Information: Therapist Exoress Basis Part number 08515289 syngo Therapist Express Part Number 08162815 syngo RT Therapist Connect/ MOSAIQ OIS Part number 08168754.
• 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 has become aware of a potential safety issue that may result in mistreatment when customers are configured with the ARTISTE Linac RT Therapist v4.2 in combination with RT Oncologist v.4.2 and use the remote "Online 2D Image Review.
• FDA Determined Cause: Software design
• Action: The firm, Siemens, sent an "Urgent: Medical Device Correction Customer Safety Advisory Notice" on March 31, 2011 via Siemens Customer Service Group or certified mail to its customers. The notice describes the product, problem and actions to be taken. The customers were instructed to not use the "Online 2D Image Review" on the Syngo RT Oncologist 4.2; to always calculate the offset directly on the RTT 4.2 before it is applied for the treatment with the patient on the treatment table; include this notice in their syngo RT Therapist 4.2 System Owner Manual chapter "Safety Advisory Letter" where it should remain until the measures defined in the notice are performed, and in the interest of safety, perform the preventative measures noted in this notice and inform all affected personnel immediately. Siemens is currently working on a solution for the incremental loading workflow in syngo RT Therapist 4.2 and will provide a software update as soon as possible. Siemens will notify the customers as soon as an update for their system will be available. UPDATE: The release of Safety Update UI TH010/11/S to distribute the software update for RTTv4.2.94O04 began on April 15, 2011. If you have any questions, contact Regulatory Affairs at 925-602-8157.
• Quantity in Commerce: 45 active devices
• Distribution: Worldwide distribution: USA (nationwide) including states of: CA, FL, OH, PA and UT; and countries including: Australia, Belgium, Croatia, Germany, Japan, South Africa, Sweden 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 and Original Applicant = HEMCON MEDICAL TECHNOLOGIES, INC.; 510(K)s with Product Code = IYE and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.