Mevion S250 and S250i Proton Therapy Systems hand pendant (P/N 10263 or P/N 37808)
Check against the official notice below — it lists the full affected range.
Mevion Medical Systems is recalling hand pendants (part numbers 10263 and 37808) used with Mevion S250 and S250i Proton Therapy Systems. The hand pendant controls the movement of the therapy couch and nozzle, but a malfunction can cause unintentional motion that could result in patient injury if they come into contact with the nozzle or other objects in the treatment room.
The recall affects 39 hand pendants worldwide (36 in the United States and 3 outside the US), distributed in Florida, Missouri, New Jersey, Ohio, Oklahoma, Utah, Washington D.C., and the Netherlands. All therapy systems and hand pendant serial numbers are affected. The source document does not specify a remedy or corrective action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
Malfunction of the hand pendant controlling movement of the therapy couch and nozzle may result in unintentional motion. Patient injury is possible if they come in contact with the nozzle or other objects in the treatment room.
Reason for recall: Malfunction of the hand pendant controlling movement of the therapy couch and nozzle may result in unintentional motion. Patient injury is possible if they come in contact with the nozzle or other objects in the treatment room. Distribution: Worldwide distribution - US Nationwide distribution in the states of FL, MO, NJ, OH, OK, UT, DC and the country of Netherlands. Quantity: 39 (36 US, 3 OUS) Lot/code info: All theryapy systems, all hand pendant serial numbers. Therapy system UDI 00864366000100 and UDI 00864366000124.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.