Recall Z-2746-2018— Mevion Medical Systems, Inc.
Class II · Terminated
Class II FDA medical device recall by Mevion Medical Systems, Inc., initiated 2018-06-29, terminated 2018-10-02. It names 2 FDA 510(k) clearances: K172848, K120676. Product: MEVION S250/MEVION S250i Proton Beam Radiation therapy system Product Usage: Indicated for the delivery of radiation for the treatment of patients with localized tumors or other conditions susceptible to treatment by radiation.. Reason: QFix has advised Mevion Medical Systems that they are identifying unauthorized combinations of QFix Couch Tops with non-QFix devices in clinical use. The kVue Oen Touch latch consists of a precision latch mechanism that can be damaged when used with incompatible (third-party) accessories. This can create unsafe conditions for use and may compromise the subsequent use of any kVue inserts, whether authorized or not. Use of unauthorized or unvalidated inserts may lead to an incorrect patient treatment or physical injury..
- Recalling firm
- Mevion Medical Systems, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-06-29
- Terminated
- 2018-10-02
- 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/MEVION S250i Proton Beam Radiation therapy system Product Usage: Indicated for the delivery of radiation for the treatment of patients with localized tumors or other conditions susceptible to treatment by radiation.
Reason for recall
QFix has advised Mevion Medical Systems that they are identifying unauthorized combinations of QFix Couch Tops with non-QFix devices in clinical use. The kVue Oen Touch latch consists of a precision latch mechanism that can be damaged when used with incompatible (third-party) accessories. This can create unsafe conditions for use and may compromise the subsequent use of any kVue inserts, whether authorized or not. Use of unauthorized or unvalidated inserts may lead to an incorrect patient treatment or physical injury.
Data sourced from openFDA. This site is unofficial and independent of the FDA.