Class 2 Device Recall ARTISTE , ONCOR and PRIMUS digital accelerators with syngo RT Therapist v4.1 and 4.2 system;

• Date Initiated by Firm: March 31, 2011
• Date Posted: May 23, 2011
• Recall Status: Terminated on March 30, 2012
• Recall Number: Z-2243-2011
• Recall Event ID: 58533
• 510(K)Number: K072486 K060226 K993425
• Product Classification: Accelerator, linear, medical - Product Code IYE
• Product: ARTISTE , ONCOR and PRIMUS digital accelerators with syngo RT Therapist v4.1 and 4.2 system;; Therapist Express Basic, syngo RT Therapist and syngo RT Therapist Connect/MOSAIQ OIS.; The ONCOR and PRIMUS may be updated to utilize the RTT v4.x software.; Distributed by Siemens, Healthcare, Concord, CA 94520; ; Radiation therapy
• Code Information: Therapist Express Basic Part number 08515289; syngo RT Therapist 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 found a potential safety issue related to patient treatment with table offsets on syngo RT Therapist (RTT) 4.1 and 4.2 which could result in dose being delivered to wrong location.
• FDA Determined Cause: Software design
• Action: Siemens initiated an Urgent Medical Device Correction letter on March 31, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to: use only relataive table setup with all planned table values '0' if applicable. In cases where the treatment plan contains at least one table parameter other than '0' to consider the following: Use only one PVG plus resulting offset per fraction. Once an offset has been applied do not use 'apply offset' at RTT for any further offset. Select the PVG and treatment beams in the same auto-sequence. In case this is not possible, the table position for each treatment beam, in the fraction, needs to be verified separately (especially for treatments with beams having different table posiitons. If an in-session resumption or individual download of beams has to be performed, make sure that the treatment table is in the correct position. In order to prevent any unintended table movement select manual table movement for all directions in the syngo RT Therapist service UI. Scenario 2 - Manual change of table posiiton followed by a PVG calculated offset. Always deliver the PVG's at the planned table position. Avoid manual change of table posiiton prior to applicaiton of PVG. Select the PVG and treatment beams in the same auto-sequence. In case this is not possible, the table position for each treatment beam, in the fraction, need to be verified separately (especially for treatments with beams having different table positions). If an in-session resumption or individual download of beams has to be performed, make sure that the treatment table is in the correct position. In order to prevent any unintended table movement select manual table movement for all directions in the syngo RT Therapist service UI. Customers were informed that a software update would be provided as soon as possible. Customers were asked to include the Customer Sa
• Quantity in Commerce: 164 active devices
• Distribution: Worldwide Distribution - USA including CA, DE, FL, KY, LA, MA, MI, MO, NC, NE, NJ, NY, OH, PA, SD, TN, UT, WI, and WV and the countries of Australia, Belgium, Canada, Croatia, Egypt, France, Germany, Hungary, India, Ireland, Italy, Japan, Malaysia, Netherlands, New Zealand, Norway, P.R. China, Philippines, Poland, Republic of Korea, Russian Federation, Saudi Arabia, South Africa, Spain, Turkey, and the 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.