| Class 2 Device Recall Mevatron KDS2 Medical Linear Accelerator | |
Date Initiated by Firm | January 11, 2008 |
Date Posted | April 02, 2008 |
Recall Status1 |
Terminated 3 on May 06, 2011 |
Recall Number | Z-1402-2008 |
Recall Event ID |
46940 |
510(K)Number | K882729 |
Product Classification |
Medical Linear Accelerator - Product Code IYE
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Product | Mevatron KDS-2 Medical Linear Accelerator, Material Number: 9822693, with control console software versions 6.5/7.2, 8.0, 9.0 and 9.1, Manufactured by Siemens Medical Solutions USA, Inc, Concord, CA |
Code Information |
Serial Numbers: 2518 and 2289 |
Recalling Firm/ Manufacturer |
Siemens Medical Solutions USA, Inc 4040 Nelson Ave Concord CA 94520-1200
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For Additional Information Contact | 925-246-8407 |
Manufacturer Reason for Recall | Linear accelerator gantry may rotate in an unexpected direction and may cause patient injury on impact. |
FDA Determined Cause 2 | Software design |
Action | This is a mandatory software upgrade for consignees. The firm's representatives have contacted consignees via Urgent Device Notification letters dated February 14, 2008, notifying them of the new update and making arrangements to install it. |
Quantity in Commerce | 2 units |
Distribution | Worldwide-USA including states of AL, AK, AZ, AR, CA, CO, DE, DC, FL, GA, IL, IN, KS, KY, LA, MD, ME, MI, MN, MS, MO, MN, NE, NV, NH, NJ, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, VT, VA, WA, WV, WI, and WY and countries of Angola, Australia, Austria,Belgium,Brazil,Canada,Chile,Colombia,Costa Rica, Croatia,Cyprus,The Czech Republic,Denmark,DPR of Korea,El Salvador,France,Germany,Greece,Hungary,India,Iran,Ireland,Italy,Japan,Jordan,Malaysia,Mexico, The Netherlands,New Zealand,Norway,P.R. China,Pakistan,Peru,Philippines,Poland,Portugal,Republic of Korea,Romania,Russian Fed.Saudi Arabia,Singapore,Slovakia,South Africa,Spain,Sweden,Taiwan,Thailand,Trinidad,Tobago,Turkey, U.A.E.,Ukraine, The United Kingdom, and Venezuela |
Total Product Life Cycle | TPLC Device Report |
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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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510(K) Database | 510(K)s with Product Code = IYE
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