Proton therapy system -Proteus 235 aka Proteus Plus. A medical device designed to produce and deliver a proton beam for
FDA device recall Z-2097-2017 · posted 2017-05-03 · Terminated
Recall details
- Recalling firm
- Ion Beam Applications S.A.
- Reason for recall
- A PBS (Pencil Beam Scanning) irradiation may pause for different reasons. After a pause, irradiation may restart from the beginning instead of recalculating the field based on the already delivered dose.
- Action taken
- Target date for software update June 30, 2017. A Field Safety Notice was issued on 4/10/2017 describing the problem and reminding users to follow guidance in the user's manual.
- Root cause
- Software design
- Status
- Terminated
- Product code
- LHN
- Quantity affected
- 2
- Distribution
- FL
- Date initiated
- 2017-04-10
- Date posted
- 2017-05-03
- Date terminated
- 2018-02-16
- Location
- Louvain La Neuve, Belgium
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Proton Therapy System - Proteus 235 (Proteus One, Proteus Plus, Proteus TK2) (K152224) | Ion Beam Application S.A. | 2016-08-09 |