Z-0698-2019 Class II Terminated
FDA device recall Z-0698-2019 was initiated by Ion Beam Applications S.A. on December 12, 2018 and is designated Class II. Reason for recall: There is a risk of detachment of the Compact Gantry Rolling Floor. The recall status is terminated (terminated April 15, 2020). Affected quantity: 7.
Recall Details
- Product Type
- Devices
- Report Date
- January 16, 2019
- Initiation Date
- December 12, 2018
- Termination Date
- April 15, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7
Product Description
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.
Reason for Recall
There is a risk of detachment of the Compact Gantry Rolling Floor.
Distribution Pattern
Worldwide Distribution - US Nationwide in the states of LA and MI. Foreign distribution to France, Japan, and UK.
Code Information
SAT.123, SBF.101, SBF.103, SBF.104, SBF.105, SBF.107, SBF.109