Recall Z-0485-2021— Mevion Medical Systems, Inc.
Class II · Terminated
Class II FDA medical device recall by Mevion Medical Systems, Inc., initiated 2020-10-19, terminated 2021-08-31. It names one FDA 510(k) clearance: K172848. Product: MEVION S250i, MEVION S250; Proton Radiation Treatment System - Product Usage: intended to deliver proton radiation treatment to patients with localized tumors or any other conditions susceptible to treatment by radiation. Reason: Treatment beam information disappears on Treatment Console screen while beam delivery continues potential for harm to a patient could occur.
- Recalling firm
- Mevion Medical Systems, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-10-19
- Terminated
- 2021-08-31
- Firm location
- Littleton, MA, United States
510(k) clearances named in this recall
1 on FDA's recordK-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 - Product Usage: intended to deliver proton radiation treatment to patients with localized tumors or any other conditions susceptible to treatment by radiation
Reason for recall
Treatment beam information disappears on Treatment Console screen while beam delivery continues potential for harm to a patient could occur
Data sourced from openFDA. This site is unofficial and independent of the FDA.