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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 Recall
Mobetron Model 1000
see related information
Date Posted October 03, 2008
Recall Status1 Open
Recall Number Z-0014-2009
Recall Event ID 49022
Product Classification System, Radiation Therapy, Charged-Particle, Medical - 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, California 94085-3528
Manufacturer Reason
for Recall
Docking screw/nut failure, which may result in a treatment head dropping, potentially impacting the patient.
FDA Determined
Cause 2
DESIGN: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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