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U.S. Department of Health and Human Services

Class 2 Device Recall ARTISTE MV System

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  Class 2 Device Recall ARTISTE MV System see related information
Date Initiated by Firm February 18, 2020
Create Date April 07, 2020
Recall Status1 Terminated 3 on February 09, 2021
Recall Number Z-1677-2020
Recall Event ID 85161
510(K)Number K072485  K103606  K121295  
Product Classification Accelerator, linear, medical - Product Code IYE
Product ARTISTE MV System Model #8139789 with Digital LINAC Systems Control Console Software Versions 6, 7, 9, 13
Code Information Serial Numbers 5350, 5410, 5419, 5481, 5500, 5488, 5532, 5540, 5548, 5572, 5590, 5601, 5630, 5640, 5657, 5699, 5707, 5737, 5743, 5748, 5755, 5784, 5823, 5843, 5844, 5851, 5899, 5833, 5894, 5830 
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 2		 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 and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
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