MEVION S250, used for proton radiation therapy.
FDA device recall Z-0588-2015 · posted 2014-12-12 · Terminated
Recall details
- Recalling firm
- Mevion Medical Systems, Inc.
- 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%.
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- LHN
- Quantity affected
- 1
- Distribution
- US Distribution in the state of MO
- Date initiated
- 2014-11-10
- Date posted
- 2014-12-12
- Date terminated
- 2015-03-18
- Location
- Littleton, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| S-250 PROTON BEAM RADIATION THERAPY SYSTEM (K120676) | Mevion Medical Systems | 2012-06-04 |