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.
Reported: August 5, 2020 Initiated: July 17, 2020 #Z-2715-2020
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.
Details
- Recalling Firm
- Ion Beam Applications S.A.
- Units Affected
- 2 Units
- Distribution
- US: VA OUS: Belgium
- Location
- Louvain-la-neuve, N/A
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Ion Beam Applications S.A.. Units affected: 2 Units.
Why was this product recalled? ▼
IBA became aware of an issue to resume aborted irradiations because the plan to complete the treatment cannot be loaded.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 5, 2020. Severity: Moderate. Recall number: Z-2715-2020.
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