MEVION S250, System, Radiation Therapy, Charged-Particle, Medical used for Proton Radiation Therapy Product Usage: Proton Radiation Therapy
Reported: April 2, 2014 Initiated: March 5, 2014 #Z-1271-2014
Product Description
MEVION S250, System, Radiation Therapy, Charged-Particle, Medical used for Proton Radiation Therapy Product Usage: Proton Radiation Therapy
Reason for Recall
Geometric positioning error can occur after a rotational correction has been applied to one or more treatment fields
Details
- Recalling Firm
- Mevion Medical Systems, Inc.
- Units Affected
- 1 unit
- Distribution
- USA Nationwide Distribution in the state of MO
- Location
- Littleton, MA
Frequently Asked Questions
What product was recalled? ▼
MEVION S250, System, Radiation Therapy, Charged-Particle, Medical used for Proton Radiation Therapy Product Usage: Proton Radiation Therapy. Recalled by Mevion Medical Systems, Inc.. Units affected: 1 unit.
Why was this product recalled? ▼
Geometric positioning error can occur after a rotational correction has been applied to one or more treatment fields
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 2, 2014. Severity: Moderate. Recall number: Z-1271-2014.
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