Mobetron Model 1000, mobile electron linear accelerator, a device system which delivers radiation to an intraoperative site.
FDA Recall Z-0014-2009 · Posted 2008-10-03
Recalling FirmIntraop Medical Corporation
Recall StatusTerminated
Product CodeLHN
Date Initiated2008-06-20
Date Terminated2011-04-05
Product Quantity24 units
Reason for Recall
Docking screw/nut failure, which may result in a treatment head dropping, potentially impacting the patient.
Firm 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.
Root Cause
Component design/selection
Distribution Pattern
Worldwide Distribution
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.