FDA Recall
Terminated
MEVION S250, used for proton radiation therapy.
Recall: Z-0588-2015
·
Initiated November 10, 2014
Recall
- Recall Number
- Z-0588-2015
- Event Number
- 69778
- Firm
- Mevion Medical Systems, Inc.
- FEI Number
- 3007087027
- Product Code
- LHN
- Status
- Terminated
- Root Cause
- Software design
- Initiated
- November 10, 2014
- Posted
- December 12, 2014
- Terminated
- March 18, 2015
- Address
- 300 Foster St, Littleton, MA, 01460-2017
Description
MEVION S250, used for proton radiation therapy.
Reason
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%.
Action
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 [email protected] or call 978-540-1555.
Distribution
US Distribution in the state of MO
Quantity
1