Intraop Medical Corporation Mobetron Model 1000, mobile electron linear accelerator, a device system which delivers radiation to an intraoperative site. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Mobetron Model 1000, mobile electron linear accelerator, a device system which delivers radiation to an intraoperative site.
Brand
Intraop Medical Corporation
Lot Codes / Batch Numbers
all units
Products Sold
all units
Intraop Medical Corporation is recalling Mobetron Model 1000, mobile electron linear accelerator, a device system which delivers radiation to due to Docking screw/nut failure, which may result in a treatment head dropping, potentially impacting the patient.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Docking screw/nut failure, which may result in a treatment head dropping, potentially impacting the patient.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026