CLASS II Device recall · Reported 29 Jul 2020 · FDA Enforcement Report
Mevion S250 Proton Radiation Treatment System recalled
Mevion Medical Systems is recalling Mevion S250 Proton Radiation Treatment System, distributed in District of Columbia, Florida, Missouri, New Jersey, Ohio, Oklahoma. The recall was initiated on 23 Jun 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2686-2020
- FDA event ID
- 86028
- Recalling firm
- Mevion Medical Systems, Littleton, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 23 Jun 2020
- FDA classified
- 22 Jul 2020
- Reported
- 29 Jul 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Other
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 23 Jun 2020 | Recall initiated by company | |
| 22 Jul 2020 | Classified by FDA | +29 days |
| 29 Jul 2020 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Product as listed by the FDA
MEVION S250 Proton Radiation Treatment System; intended to deliver proton radiation treatment to patients
Where it was distributed
MO, NJ, OK, FL, OH, DC, Netherlands
Questions about this recall
Is Mevion S250 Proton Radiation Treatment System recalled?
Yes. Mevion Medical Systems recalled Mevion S250 Proton Radiation Treatment System on 23 Jun 2020. The recall is Class II and its status is Terminated. Recall number Z-2686-2020.
Why was it 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.
Which lots are affected?
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
Where was it sold?
MO, NJ, OK, FL, OH, DC, Netherlands
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Mevion Medical Systems
All 14| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Mevion S250 and S250i Proton Therapy Systems hand pendant recalled | Mevion Medical Systems | Device Malfunction | Nationwide |
| Device | CLASS II | Mevion S250i, Mevion S250 recalled by Mevion Medical Systems | Mevion Medical Systems | Other | Nationwide |
| Device | CLASS II | Mevion S250i, Mevion S250 recalled by Mevion Medical Systems | Mevion Medical Systems | Other | 6 states |
| Device | CLASS II | Mevion S250i recalled by Mevion Medical Systems | Mevion Medical Systems | Other | DC |
| Device | CLASS II | Mevion S250/Mevion S250i Proton Beam Radiation therapy system recalled | Mevion Medical Systems | Lead & Heavy Metals | Nationwide |
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