Recall Z-2406-2020— Mevion Medical Systems, Inc.
Class II · Terminated
Class II FDA medical device recall by Mevion Medical Systems, Inc., initiated 2020-05-15, terminated 2020-12-11. It names 2 FDA 510(k) clearances: K172848, K120676. Product: MEVION S250i, MEVION S250; Proton Radiation Treatment System. Reason: Couch Correction moves sent after using a 3D CT scan are partially lost if the previous correction sent or recorded had some of the Couch Correction checkboxes turned off.
- Recalling firm
- Mevion Medical Systems, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-05-15
- Terminated
- 2020-12-11
- 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 S250i, MEVION S250; Proton Radiation Treatment System
Reason for recall
Couch Correction moves sent after using a 3D CT scan are partially lost if the previous correction sent or recorded had some of the Couch Correction checkboxes turned off
Data sourced from openFDA. This site is unofficial and independent of the FDA.