Reported Jul 29, 2020 · Terminated
MEVION S250 Proton Radiation Treatment System; intended to deliver proton radiation treatment to patients
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 Proton Radiation Treatment System; intended to deliver proton radiation treatment to patients
- Lot codes and dates
- Lot #s: MEVION S250-0001 MEVION S250-0002 MEVION S250-0003 MEVION S250-0004 MEVION S250-0005 MEVION S250-0006
- MEVION S250-0007 MEVION S250-0008 UDI(01)00864366000100 (11) 131209 (01)00864366000100 (11)150526 (01)00864366000100 (11)150113 (01)00864366000100 (11)150430 (01)00864366000100 (11)160127 (01)00864366000100 (11)160603 (01)00864366000124 (11) 180220 (01)00864366000124 (11) 181219
- Amount recalled
- 8 units
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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