Recall Z-0014-2009 ยท LHN System, Radiation Therapy, Charged-Particle, Medical
Intraop Medical Corporation
Mobetron Model 1000, mobile electron linear accelerator, a device system which delivers radiation to an intraoperative site.
| Date | Oct 3, 2008 (initiated Jun 20, 2008) |
| Status | Terminated |
| Reason | Docking screw/nut failure, which may result in a treatment head dropping, potentially impacting the patient. |
| 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 | 24 units |
| Distribution | Worldwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K981112 | MOBETRON Intraop Medical, Inc., Jul 24, 1998 |