MEVION S250 Product Usage: Proton Radiation Therapy
FDA device recall Z-0409-2017 · posted 2016-11-15 · Terminated
Recall details
- Recalling firm
- Mevion Medical Systems, Inc.
- Reason for recall
- Completing Setup Without Program Move Complete Can Cause An Isocenter Error
- Action taken
- Mevion issued an Important Safety Notice letter on October 31, 2016 to customers. The identified the affected product, problem, mitigation and advisory information. The letter informed customers that Mevion will release and install a software patch that removes the reliance on tracking isocenter changes for the correct reporting of the Couch position to the user displays and to the OIS. For further information mailto:srosenthal@mevion.com
- Root cause
- Software design
- Status
- Terminated
- Product code
- MUJ
- Quantity affected
- 6 units
- Distribution
- US Nationwide in the states of FL, MO, NJ and OK
- Date initiated
- 2016-10-31
- Date posted
- 2016-11-15
- Date terminated
- 2017-06-29
- Location
- Littleton, MA
Monitor recalls programmatically
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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 |