MEVION S250-Proton Radiation Therapy Product Usage: Proton Radiation Therapy
FDA device recall Z-1122-2017 · posted 2017-02-02 · Terminated
Recall details
- Recalling firm
- Mevion Medical Systems, Inc.
- Reason for recall
- An error can occur causing Delta corrections to be lost when one setup field is closed and another is opened
- Action taken
- Mevion sent an Important Safety Notice to customers on 12/16/16 by email and Salesforce. The letter identified the affected product, problem and actions to be taken. Mevion provided mitigation and will release and install a software patch that removes the possibility that Deltas can be lost between multiple Setup fields. For further information contact rcessac@mevion.com.
- Root cause
- Software design
- Status
- Terminated
- Product code
- LHN
- Quantity affected
- 2 units
- Distribution
- US Nationwide in the states of OK, NJ
- Date initiated
- 2016-12-16
- Date posted
- 2017-02-02
- Date terminated
- 2017-04-13
- 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 |