Z-0943-2018 Class II Terminated
FDA device recall Z-0943-2018 was initiated by Ion Beam Applications S.A. on November 1, 2017 and is designated Class II. Reason for recall: The internal configuration of the electrometers and the Real-Time control boards of the Dekimo Scanning Controller is not checked before each patient treatment. The recall status is terminated (terminated March 29, 2019). Affected quantity: 3.
Recall Details
- Product Type
- Devices
- Report Date
- March 21, 2018
- Initiation Date
- November 1, 2017
- Termination Date
- March 29, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3
Product Description
Proteus 235, Pencil Beam Scanning, PTS-9.4.X, PTS-10.0.1.1 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
The internal configuration of the electrometers and the Real-Time control boards of the Dekimo Scanning Controller is not checked before each patient treatment.
Distribution Pattern
Worldwide Distribution: US (nationwide) to: MI only and country of: France.
Code Information
SBF.101 (EU), SBF.105 (US)