CLASS II Device recall · Reported 17 Feb 2016 · FDA Enforcement Report
Mevion S250 Radiation therapy system recalled by Mevion Medical Systems
Mevion Medical Systems is recalling Mevion S250 Radiation therapy system, distributed nationwide in the US. The recall was initiated on 18 Nov 2015 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-0767-2016
- FDA event ID
- 72210
- Recalling firm
- Mevion Medical Systems, Littleton, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 18 Nov 2015
- FDA classified
- 8 Feb 2016
- Reported
- 17 Feb 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Processing Deviation
- Device type
- Other Medical Devices
Timeline
| 18 Nov 2015 | Recall initiated by company | |
| 8 Feb 2016 | Classified by FDA | +82 days |
| 17 Feb 2016 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The treatment table positioning belt can slip gear positions, resulting in deviation of patient setup and treatment positions from the time of slippage until the discovery of slippage and the halting of treatment.
The USDA issues these when meat or poultry was produced without proper inspection, or when a step such as cooking or pasteurisation did not meet requirements.
Product as listed by the FDA
MEVION S250 Radiation therapy system
Where it was distributed
US nationwide distribution including FL, NJ, OK, and MO.
Questions about this recall
Is Mevion S250 Radiation therapy system recalled?
Yes. Mevion Medical Systems recalled Mevion S250 Radiation therapy system on 18 Nov 2015. The recall is Class II and its status is Terminated. Recall number Z-0767-2016.
Why was it recalled?
The treatment table positioning belt can slip gear positions, resulting in deviation of patient setup and treatment positions from the time of slippage until the discovery of slippage and the halting of treatment.
Which lots are affected?
Manufacturing Lot or Serial Number: S250-0004
Where was it sold?
US nationwide distribution including FL, NJ, OK, and 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 |
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