Recall Z-1529-2016 ยท LHN System, Radiation Therapy, Charged-Particle, Medical
Mevion Medical Systems, Inc.
MEVION S250 for Proton Radiation Therapy
| Date | Apr 20, 2016 (initiated Mar 15, 2016) |
| Status | Terminated |
| Reason | Possibility of Gantry Motion with Aperture or Compensator only partially inserted. An Aperture may fall out during Gantry motion. It is possible that it can hit a patient and cause traumatic injury or death. |
| Root cause | Device Design |
| Action | Customer notification letters were sent to customers on March 15, 2016, by certified mail, return receipt requested, as well as by email. The letter explains the problem, description of potential harm, and the cause containment, and mitigation. The cause of the malfunctioning sensors was discovered to be a non-conforming limit switch assembly. A Mevion Field Service Engineer will immediately inspect all such parts in the field for similar non-conformance, and replace those parts if necessary. In addition, a new periodic preventive maintenance check will be performed to individually test each |
| Quantity | 5 |
| Distribution | US nationwide distribution to MO, OK, FL, and NJ. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K120676 | S-250 PROTON BEAM RADIATION THERAPY SYSTEM Mevion Medical Systems, Jun 4, 2012 |