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U.S. Department of Health and Human Services

Class 2 Device Recall Mobetron Model 1000

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  Class 2 Device Recall Mobetron Model 1000 see related information
Date Initiated by Firm June 20, 2008
Date Posted October 03, 2008
Recall Status1 Terminated 3 on April 05, 2011
Recall Number Z-0014-2009
Recall Event ID 49022
510(K)Number K981112  
Product Classification Medical Charged-Particle Radiation Therapy System - Product Code LHN
Product Mobetron Model 1000, mobile electron linear accelerator, a device system which delivers radiation to an intraoperative site.
Code Information all units
Recalling Firm/
Manufacturer		 Intraop Medical Corporation
570 Del Rey Ave
Sunnyvale CA 94085-3528
For Additional Information Contact
408-636-1020 Ext. 109
Manufacturer Reason
for Recall		 Docking screw/nut failure, which may result in a treatment head dropping, potentially impacting the patient.
FDA Determined
Cause 2		 Component design/selection
Action Recall initiated on 06/20/2008, advising users via Advisory Notice that a safety upgrade would be available. Two options are given to either self inspect the product or schedule an Intraop Authorized Field Service Engineer to visit their facility to perform the inspection. The letter notes that if no nut failure was evident, the machine could still be used. The firm continues to send retrofit kits.
Quantity in Commerce 24 units
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.
510(K) Database 510(K)s with Product Code = LHN and Original Applicant = INTRAOP MEDICAL, INC.
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