CLASS II Device recall · Reported 17 Dec 2014 · FDA Enforcement Report
Mevion S250, used for proton radiation therapy recalled
Mevion Medical Systems is recalling Mevion S250, used for proton radiation therapy, distributed in Missouri. The recall was initiated on 10 Nov 2014 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-0588-2015
- FDA event ID
- 69778
- Recalling firm
- Mevion Medical Systems, Littleton, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 Nov 2014
- FDA classified
- 11 Dec 2014
- Reported
- 17 Dec 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Temperature Abuse
- Device type
- Other Medical Devices
Timeline
| 10 Nov 2014 | Recall initiated by company | |
| 11 Dec 2014 | Classified by FDA | +31 days |
| 17 Dec 2014 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Software defect that causes an incorrect dose compensation function to be applied to the internal dose ionization chamber when either pressure or temperature sensor malfunction. This could result in an incorrect dose delivery of no more than 5%.
Foods that need refrigeration and were stored or shipped too warm can grow harmful bacteria without any change in look or smell.
Product as listed by the FDA
MEVION S250, used for proton radiation therapy.
Where it was distributed
US Distribution in the state of MO
Questions about this recall
Is Mevion S250, used for proton radiation therapy recalled?
Yes. Mevion Medical Systems recalled Mevion S250, used for proton radiation therapy on 10 Nov 2014. The recall is Class II and its status is Terminated. Recall number Z-0588-2015.
Why was it recalled?
Software defect that causes an incorrect dose compensation function to be applied to the internal dose ionization chamber when either pressure or temperature sensor malfunction. This could result in an incorrect dose delivery of no more than 5%.
Which lots are affected?
Serial Number: S250-0001
Where was it sold?
US Distribution in the state of MO
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 S250 Proton Radiation Treatment System recalled | Mevion Medical Systems | Other | 6 states |
| 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 |
Other Other Medical Devices recalls
All 13,778| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Citric Complete Dry Citric Acid Concentrate recalled | Nipro Renal Soultions USA | Other | Nationwide |
| Device | CLASS I | Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | Halyard IV Start Kit Non-Sterile recalled by Avid Medical | Avid Medical | Sterility | Nationwide |
| Device | CLASS I | Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | AMS Convenience Kit: Dsaek Pack - RX recalled | Windstone Medical Packaging | Device Malfunction | Nationwide |