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U.S. Department of Health and Human Services

Class 2 Device Recall Mevatron Linear Accelerator Systems

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 Class 2 Device Recall Mevatron Linear Accelerator Systemssee related information
Date Initiated by FirmJuly 27, 2007
Date PostedFebruary 19, 2008
Recall Status1 Terminated 3 on April 29, 2011
Recall NumberZ-0851-2008
Recall Event ID 45991
510(K)NumberK862339 
Product Classification Linear Accelerator System - Product Code IYE
ProductSiemens Mevatron Linear Accelerator Systems: KD2, K 7767, K 8067, KD, KDS and KDS2, Mevatron KD2, Part No.: 1940753; Mevatron KD2, Part No.: 08515520; Mevatron KD2-Part No.: 9822685; Mevatron K 7767, Part No.: 5694302; Mevatron K 8067, Part No.: 5694401; Mevatron KD, Part No.: 8319857; Mevatron KDS, Part No.: 9401522; Mevatron KDS2, Part No.: 9411588; and Mevatron KDS2, Part No.: 9822693, Siemens Medical Solutions USA, Inc., Concord, CA
Code Information All Serial Numbers
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		Door Hinge failures; loose or falling off (Stationary Structure Doors)
FDA Determined
Cause 2		Component design/selection
ActionStationary Door Hinges will be replaced on each device by the recalling firm's technician visits.
Quantity in Commerce1,284 total for recalls Z-0850-0852-2008
DistributionWorldwide- USA including the states of Missouri, Georgia, Delaware, Texas, Ohio, Alabama, Kentucky, Florida, California, North Carolina, New Jersey, New York, Illinois, Pennsylvania, Colorado, Tennessee, Arizona, Pennsylvania, Virginia, New Jersey, Michigan, Wisconsin, Indiana, Nebraska, Montana, Kansas, Mississippi, Rhode Island, Washington, South Carolina, Maryland, New Hampshire, Maine, Arkansas, Idaho, Missouri, Louisiana, Oklahoma, North Dakota, Minnesota, Massachusetts, and The District of Columbia and countries of Canada and Mexico.
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
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