Proteus 235
FDA device recall Z-1695-2017 · posted 2017-03-23 · Terminated
Recall details
- Recalling firm
- Ion Beam Applications S.A.
- Reason for recall
- The Proton Therapy System can allow gantry rotation even if the snout is not properly locked.
- Action taken
- A Field Safety Notice was mailed or handed to affected customers to inform them of the issue. The notice provides information on the issue, the risk for the patient and user and actions to be taken before starting gantry rotation. Corrective action developed by IBA are detailed.
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- LHN
- Quantity affected
- 8 worldwide, 4 in U.S.
- Distribution
- Distributed in MA, FL, VA, and TN. China, South Korea, France and Germany
- Date initiated
- 2017-03-09
- Date posted
- 2017-03-23
- Date terminated
- 2019-03-26
- Location
- Louvain La Neuve, Belgium
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODIFICATION TO IBA PROTON THERAPY SYSTEM-PROTEUS 235 (K101508) | Ion Beam Applications S.A. | 2010-08-06 |