Recall Z-0827-2022— Mevion Medical Systems, Inc.
Class II · Ongoing
Class II FDA medical device recall by Mevion Medical Systems, Inc., initiated 2022-02-01. It names 2 FDA 510(k) clearances: K172848, K120676. Product: Mevion S250 and S250i Proton Therapy Systems hand pendant (P/N 10263 or P/N 37808). Reason: 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..
- Recalling firm
- Mevion Medical Systems, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-02-01
- Firm location
- Littleton, MA, United States
510(k) clearances named in this recall
2 on FDA's record- K172848 — MEVION S250i Proton Beam Radiation Therapy Device
- K120676 — S-250 PROTON BEAM RADIATION THERAPY SYSTEM
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Mevion S250 and S250i Proton Therapy Systems hand pendant (P/N 10263 or P/N 37808)
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.