Proteus 235 Product Usage: The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. The PTS may include a fixed small beam treatment room dedicated to the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation localized to the head and neck.
This recall has been terminated (originally issued December 12, 2018).
- Recall Initiated
- December 12, 2018
- Terminated
- April 15, 2020
- Recall Number
- Z-0698-2019
- Quantity
- 7
- Official Source
- View on FDA website ↗
Reason for Recall
There is a risk of detachment of the Compact Gantry Rolling Floor.
Distribution
Worldwide Distribution - US Nationwide in the states of LA and MI. Foreign distribution to France, Japan, and UK.
Lot / Code Info
SAT.123, SBF.101, SBF.103, SBF.104, SBF.105, SBF.107, SBF.109
Root Cause
Device Design
Action Taken
On December 12, 2018, the firm notified its customers of the recall via an Urgent Medical Device Correction letter. Customers were informed of the product issue. Customers were reminded that nobody should stand on the rolling floor when the gantry is rotating, as specified in the Clinical User Guide. The recalling firm stated they would take the following actions: Short-term action: IBA will replace the rod end bearings attaching the cGRF to the nozzle via a preventive maintenance on all ProteusONE sites. Long-term action: A new design of the anchoring system of the cGRF to the nozzle will be deployed on all impacted sites via an upgrade kit by end of October 2019. Customers with questions should contact Sylviane BERGER Vigilance@iba-group.com +32 10 203 787, or Helpdesk +32 2 507 20 81 (available 24/7)