IBA Proton Therapy System - PROTEUS 235. PTS-11 versions, PTS-12 versions with Orion PPS version OSS6.0. Configured with
FDA device recall Z-0295-2024 · posted 2023-11-14 · Open, Classified
Recall details
- Recalling firm
- Ion Beam Applications S.A.
- Reason for recall
- The patient positioning system can perform motions in unexpected directions, creating the potential for crushing of the patient between the patient positioning devices.
- Action taken
- An Urgent Medical Device Correction issued on October 4, 2023 by email or in-person visit. Waiting for the solution to be deployed, IBA requires the user to only request jog translation motions to recover from a collision situation. IBA also recommends the user to post the notice near the device to remind them of this requirement until the software correction can be deployed. IBA provide an updated Urgent Medical Device Correction notification by November 30, 2023 with a target date for deployment of the software solution to your site. Customers are to complete and return the acknowledgement form to IBA. IBA Contact: Sonia Pinel Head of Post Market Vigilance, Email: Vigilance@iba-group.com, Helpdesk: +32 2 507 20 81 (available 24/7).
- Root cause
- Device Design
- Status
- Open, Classified
- Product code
- LHN
- Quantity affected
- 5 (US), 9 (OUS)
- Distribution
- Worldwide - US Nationwide distribution in the states of Arkansas, Florida, Kansas, and Virginia and the countries of Belgium, France, India, Italy, Netherlands, Spain, Singapore, and Taiwan.
- Date initiated
- 2023-09-18
- Date posted
- 2023-11-14
- Location
- Ottignies-Louvain-La-Neuve, Belgium
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| IBA Proton Therapy System- Proteus 235 (Proteus One, Proteus Plus, Proteus TK2, Proteus Class) (K163500) | Ion Beam Applications S.A. | 2017-08-17 |