Littleton, MA, United States
Mevion Medical Systems, Inc. recalls
6 recalls recorded since 2018, most recently on 1 February 2022. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls6
Ongoing (FDA)1
Terminated or completed5
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 1 February 2022
- 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.
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of FL, MO, NJ, OH, OK, UT, DC and the country of Netherlands.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0827-2022
- Mevion S250 and S250i Proton Therapy Systems hand pendant (P/N 10263 or P/N 37808)
Terminated Class II Medical devices
- Recall started
- 19 October 2020
- Terminated
- 31 August 2021
- Reason
- Treatment beam information disappears on Treatment Console screen while beam delivery continues potential for harm to a patient could occur
- Distribution
- Worldwide distribution - US Nationwide distribution including in the states of DC, FL, MO, NJ, OK and the country of Netherlands.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0485-2021
- 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
Terminated Class II Medical devices
- Recall started
- 23 June 2020
- Terminated
- 9 December 2020
- Reason
- The perforated screen that divides the inside of the process water tank has a very sharp edge across the top of the Heat Exchanger leading to potential injury for servicer.
- Distribution
- MO, NJ, OK, FL, OH, DC, Netherlands
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2686-2020
- MEVION S250 Proton Radiation Treatment System; intended to deliver proton radiation treatment to patients
Terminated Class II Medical devices
- Recall started
- 15 May 2020
- Terminated
- 11 December 2020
- 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
- Distribution
- Distribution to US in MO, NJ, OH, OK, FL, and DC, and the Netherlands
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2406-2020
- MEVION S250i, MEVION S250; Proton Radiation Treatment System
Terminated Class II Medical devices
- Recall started
- 1 October 2018
- Terminated
- 10 April 2020
- Reason
- Treatment is allowed to continue (via partials) in situations where dDose1 interlock has tripped
- Distribution
- DC
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0705-2019
Terminated Class II Medical devices
- Recall started
- 29 June 2018
- Terminated
- 2 October 2018
- 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.
- Distribution
- US Nationwide Distribution in the states of DC, FL, MO, NJ, OH, and OK.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2746-2018
- 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
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.