MEVION S250, used for proton radiation therapy.
This recall has been terminated (originally issued December 12, 2014).
- Company
- Mevion Medical Systems, Inc.
- Recall Initiated
- November 10, 2014
- Posted
- December 12, 2014
- Terminated
- March 18, 2015
- Recall Number
- Z-0588-2015
- Quantity
- 1
- Firm Location
- Littleton, MA
- Official Source
- View on FDA website ↗
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%.
Distribution
US Distribution in the state of MO
Lot / Code Info
Serial Number: S250-0001
Root Cause
Software design
Action Taken
Mevion Medical Systems sent an Important Safety Notice letter to the affected customer. The letter identified the affected product, problem and actions to be taken. A software update addressing the issue will be provided to the customer on or about December 5, 2014. For questions or concerns, email lbouchet@mevion.com or call 978-540-1555.