Reported Aug 22, 2018 · Terminated
MEVION S250/MEVION S250i Proton Beam Radiation therapy system Product Usage: Indicated for the delivery of radiation…
Mevion Medical Systems, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Mevion Medical Systems, Inc. · 300 Foster St · Littleton, MA · 01460-2017
Is this the product you have?
- MEVION S250/MEVION S250i Proton Beam
- Radiation therapy system Product UsageIndicated for the delivery of radiation for the treatment of patients with localized tumors or other conditions susceptible to treatment by radiation
- Lot codes and dates
- S250-0001 through S250-0006 and S250i-0007
- Amount recalled
- 7
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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