Z-0931-2018 Class II Terminated
FDA device recall Z-0931-2018 was initiated by Ion Beam Applications S.A. on October 19, 2017 and is designated Class II. Reason for recall: Range for the same energy could be different depending if the layer is the first layer of the irradiation plan or not. The recall status is terminated (terminated April 2, 2019). Affected quantity: 3.
Recall Details
- Product Type
- Devices
- Report Date
- March 14, 2018
- Initiation Date
- October 19, 2017
- Termination Date
- April 2, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3
Product Description
Proteus 235, Pencil Beam Scanning version PTS-6.4.11.X 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
Range for the same energy could be different depending if the layer is the first layer of the irradiation plan or not.
Distribution Pattern
US Distribution to the state of :FL
Code Information
PAT.003 (KR), PAT.006 (US)