MEVION S250 Radiation therapy system
FDA device recall Z-0767-2016 · posted 2016-02-08 · Terminated
Recall details
- Recalling firm
- Mevion Medical Systems, Inc.
- Reason for recall
- The treatment table positioning belt can slip gear positions, resulting in deviation of patient setup and treatment positions from the time of slippage until the discovery of slippage and the halting of treatment.
- Action taken
- Customer notification letter was sent via certified mail on November 18, 2015. The notification explains the issue and actions to be taken by the customer.
- Root cause
- Labeling design
- Status
- Terminated
- Product code
- LHN
- Quantity affected
- 4
- Distribution
- US nationwide distribution including FL, NJ, OK, and MO.
- Date initiated
- 2015-11-18
- Date posted
- 2016-02-08
- Date terminated
- 2017-04-03
- Location
- Littleton, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| S-250 PROTON BEAM RADIATION THERAPY SYSTEM (K120676) | Mevion Medical Systems | 2012-06-04 |