MEVION S250, System, Radiation Therapy, Charged-Particle, Medical used for Proton Radiation Therapy Product Usage: Proton Radiation Therapy
- Company
- Mevion Medical Systems, Inc.
- Recall Initiated
- March 5, 2014
- Posted
- March 22, 2014
- Terminated
- April 3, 2014
- Recall Number
- Z-1271-2014
- Quantity
- 1 unit
- Firm Location
- Littleton, MA
Reason for Recall
Geometric positioning error can occur after a rotational correction has been applied to one or more treatment fields
Distribution
USA Nationwide Distribution in the state of MO
Lot / Code Info
S250-0001
Root Cause
Software design
Action Taken
Mervion issued an Important Safety Notice letter on March 5, 2014 by visit to sites to the single customer using the product to prevent the use of multiple isocenters treatment modalities. The letter identified the affected product, problem and actions to be taken. For questions call 978-540-1555.
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