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U.S. Department of Health and Human Services

Class 2 Device Recall ARTISTE, ONCOR, MEVATRON, and PRIMUS Digital Linear Accelerators

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  Class 2 Device Recall ARTISTE, ONCOR, MEVATRON, and PRIMUS Digital Linear Accelerators see related information
Date Initiated by Firm August 13, 2010
Date Posted January 18, 2011
Recall Status1 Terminated 3 on January 31, 2012
Recall Number Z-0907-2011
Recall Event ID 56773
Product Classification Linear Medical Accelerator - Product Code IYE
Product ARTISTE and ONCOR Digital Linear Accelerators configured with the 160 leaf Multi-Leaf Collimator (MLC) and MEVATRON and PRIMUS Digital Linear Accelerators configured with the High Performance Defining Collimator (HPD); Product is manufactured by Kemnath, Germany-Siemens AG OCS and Siemens AG, Erlangen, Germany-Siemens AG OCS and distributed by Siemens Medical Solutions, Oncology Care Systems, Concord, CA;

Intended to deliver x-ray radiation for therapeutic treatment of cancer.

ARTISTE with 160 MLC, Part No.8139789,
ONCOR AG with 160 MLC, Part No.5863472
ONCOR Impression
Plus with 160 MLC, Part No.5857912,
ONCOR Expression with 160 MLC, Part No.7360204,
ONCOR Expression with 160 MLC, Part No.7360717,
PRIMUS HI with HPD, Part No. 4504200,
MEVATRON M2 / PRIMUS Mid-Energy / HPD, Part No.1940035,
MEVATRON 6323-2 / HPD, Part No.19244500,
MEVATRON K2 / HPD, Part No.1940753,
MEVATRON PRIMART / HPD, Part No.5500371,
MEVATRON 77 / HPD, Part No.5659503,
MEVATRON M 7400 / 7440 (MEX) / HPD, Part No.5672977,
MEVATRON M 6700 (MX) / HPD, Part No.5693908,
MEVATRON M 6730 / HPD, Part No.5694005,
MEVATRON M 7140 / HPD, Part No.5694104,
MEVATRON M 7400 / HPD, Part No.5694153,
MEVATRON M 7445 / HPD (MEX), Part No.5694203,
MEVATRON K 7467 / HPD, Part No.5694252,


MEVATRON K 7767 / HPD, Part No.5694302,
MEVATRON K 8067 / HPD, Part No.5694401,
MEVATRON M 6300 (MX) / HPD, Part No.8317000,
MEVATRON M 6730/6740 (MEX) / HPD, Part No.8319758,
MEVATRON MD (MD, MDX) / HPD, Part No.8319808,
MEVATRON KD / HPD, Part No.8319857,
MEVATRON MDX / HPD, Part No.8496200,
MEVATRON KD-2 / HPD, Part No.8515520,
MEVATRON M3 6300 / HPD, Part No.9401316,
MEVATRON M2 6700 / HPD, Part No.9401407,
MEVATRON M2 6740 / HPD, Part No.9401506,
MEVATRON KDS / HPD, Part No.941522,
MEVATRON MD-2 / HPD, Part No.9401654,
MEVATRON MDX  2 / HPD, Part No.9401746,
MEVATRON KDS-2 / HPD, Part No.9411588,
MEVATRON KD-2 / HPD, Part No.9822685,
MEVATRON KDS-2 / HPD, Part No.9822693
Code Information All units of these models.
Recalling Firm/
Manufacturer		 Siemens Medical Solutions, Oncology Care Systems, 4040 Nelson Ave., Concord, CA 94510
4040 Nelson Ave
Concord CA 94520-1200
For Additional Information Contact Christine Dunbar
925-602-8157
Manufacturer Reason
for Recall		 The potential safety issue with the 160MLC or the HPD collimator of mechanical noises and/or sticking of the collimator when rotating the collimator. The potential for mistreatment to a patient should the collimator not be aligned correctly if the bearings are damaged.
FDA Determined
Cause 2		 Pending
Action Urgent: Medical Device Correction Safety Advisory Notice letters were sent by certified mail commencing August 3, 2010. The letter described the issue and when it occurs, the measures users could take, and how Siemens would address the issue. It is recommended that customers include a check of the field alignment at 90 and 270 degrees gantry angle in the daily check prior to start of patient treatments. A copy of the Safety Advisory Notice should be included in the Owner's Manual and questions should be directed towards the local Siemens Service Engineer or Application Specialist.
Quantity in Commerce 1167
Distribution Worldwide Distribution.
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.
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