Z-0014-2009

Mobetron Model 1000, mobile electron linear accelerator, a device system which delivers radiation to an...

Name: Z-0014-2009 Mobetron Model 1000, mobile electron linear accelerator, a device system which delivers radiation to an...
Creator: Intraop Medical Corporation
Published: 2008-06-20
License: https://open.fda.gov/license/

Intraop Medical Corp. / initiated 2008-06-20 / Terminated / root cause: design

FDA source

Intraop Medical Corporation began a recall of Mobetron Model 1000, mobile electron linear accelerator, a device system which delivers radiation to an intraoperative site on 2008-06-20. The reason FDA records is "Docking screw/nut failure, which may result in a treatment head dropping, potentially impacting the patient". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0014-2009
Status: Terminated
Initiated: 2008-06-20
Posted: 2008-10-03
Terminated: 2011-04-05
Recalling firm: Intraop Medical Corp.
Product: Mobetron Model 1000, mobile electron linear accelerator, a device system which delivers radiation to an intraoperative site.
Product code: LHN System, Radiation Therapy, Charged-Particle, Medical
Reason for recall: Docking screw/nut failure, which may result in a treatment head dropping, potentially impacting the patient.
Root cause tag: design
FDA root cause: 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
Product codes and lots: all units

Product code LHN

K981112Class IIMobetronIntraop Medical, Inc. / cleared 1998-07-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)