Z-2715-2020 Class II Terminated
FDA device recall Z-2715-2020 was initiated by Ion Beam Applications S.A. on July 17, 2020 and is designated Class II. Reason for recall: IBA became aware of an issue to resume aborted irradiations because the plan to complete the treatment cannot be loaded. The recall status is terminated (terminated August 30, 2021). Affected quantity: 2 Units.
Recall Details
- Product Type
- Devices
- Report Date
- August 5, 2020
- Initiation Date
- July 17, 2020
- Termination Date
- August 30, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2 Units
Product Description
Proteus 235 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.
Reason for Recall
IBA became aware of an issue to resume aborted irradiations because the plan to complete the treatment cannot be loaded.
Distribution Pattern
US: VA OUS: Belgium
Code Information
Serial Number: Manufacture date SAT.140 (US): manufactured May 2019 SBF.112 (EU): manufactured October 2019