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U.S. Department of Health and Human Services

Class 2 Device Recall Primus Linear Accelerator System

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  Class 2 Device Recall Primus Linear Accelerator System see related information
Date Initiated by Firm July 27, 2007
Date Posted February 19, 2008
Recall Status1 Terminated 3 on April 29, 2011
Recall Number Z-0850-2008
Recall Event ID 45991
510(K)Number K993425  
Product Classification Linear Accelerator System - Product Code IYE
Product Siemens Primus Linear Accelerator System, PRIMART MX Linear Accelerator System; PRIMUS Mid, Part Number:1940035 and PRIMART MX, Part Number: 5500371, Siemens Medical Solutions USA, Inc., Concord, CA
Code Information All Serial Numbers up to Serial Number: 3532
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
Action Stationary Door Hinges will be replaced on each device by the recalling firm's technician visits.
Quantity in Commerce 1,284 total for recalls Z-0850-0852-2008
Distribution Worldwide- 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 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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