• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Mevatron KDS2 Medical Linear Accelerator

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Mevatron KDS2 Medical Linear Acceleratorsee related information
Date Initiated by FirmJanuary 11, 2008
Date PostedApril 02, 2008
Recall Status1 Terminated 3 on May 06, 2011
Recall NumberZ-1402-2008
Recall Event ID 46940
510(K)NumberK882729 
Product Classification Medical Linear Accelerator - Product Code IYE
ProductMevatron 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
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
ActionThis 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 Commerce2 units
DistributionWorldwide-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 CycleTPLC 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) Database510(K)s with Product Code = IYE
-
-