Class 2 Device Recall Siemens branded ARTISTE, MEVATRON, ONCOR, and PRIMUS

• Date Initiated by Firm: February 18, 2020
• Create Date: April 07, 2020
• Recall Status: Terminated on February 09, 2021
• Recall Number: Z-1678-2020
• Recall Event ID: 85161
• 510(K)Number: K882729 K982513
• Product Classification: Accelerator, linear, medical - Product Code IYE
• Product: MEVATRON M2/Primus Mid-Energy Model #01940035, MEVATRON PRIMART #05500371, MEVATRON KD-2 #08515520, MEVATRON KD2 #01940753, MEVATRON M-2 6740 #09401506, MEVATRON MD-2 #09401654, MEVATRON MDX-2 #09401746 with Digital LINAC Systems Control Console Software Versions 6, 7, 9, 13
• Code Information: Serial Numbers 2507, 2516, 2596, 2689, 2818, 2962, 3013, 3103, 3089, 3136, 2855, 3296, 3397, 3591, 3629, 3639, 3644, 3702, 3873, 3939, 4018, 3986, 70-4146, 70-4347, 70-4363, 5092, 5114, 5523, 70-4287, 2045, 2067, 2125
• Recalling Firm/ Manufacturer: Siemens Medical Solutions USA, Inc; 40 Liberty Blvd; Malvern PA 19355-1418
• For Additional Information Contact: Ms. Rebecca Tudor; 610-219-4834
• Manufacturer Reason for Recall: Potential safety issue with the dose monitoring system safety interlocks which could result in a 10-20% overdose of radiation therapy.
• FDA Determined Cause: Use error
• Action: A Customer Safety Advisory Notice was sent to all affected consignees on 2/18/2020 via Adobe Mega Sign or USPS certified mail. The notice describes the interlock scenarios, provides user instructions, and warns the user of potential risks. The interlock scenarios are as follows: MONITOR 2: Monitor 2 total dose coincidence. Intent: This interlock is intended to prevent overdose when the primary dose monitory system fails to complete the treatment. TREATMENT TIME: Preset treatment time coincidence with actual treatment time. Intent: This interlock is intended to prevent overdose if preset treatment time is exceeded. MONITOR SYNC (SW): Excessive accumulated dose deviation detected between the primary and the secondary dose monitoring systems. Intent: This interlock is intended to prevent patient mistreatment due to the inaccurate monitoring of delivered dose. When one or more of the above described interlocks occur, it may be assumed that there is an error in the dose monitor system.The Consumer Safety Advisory Notice states that the Operator's Manual Instructions Update document should be added to the product's manual and all users should be informed of the issues.
• Quantity in Commerce: 1012
• Distribution: Worldwide distribution. US consignees in the following states: Alabama, California, Delaware, Florida, Georgia, Iowa, Illinois, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Wisconsin, West Virginia, Wyoming
• 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; 510(K)s with Product Code = IYE