Proteus235- Proton Therapy System: to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation
Reported: June 8, 2022 Initiated: April 20, 2022 #Z-1205-2022
Product Description
Proteus235- Proton Therapy System: 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
First layer of Uniform Scanning treatment fields is sometimes irradiated with incorrect Scanning Magnet setpoints resulting in the field size may be smaller than expected and the irradiated area may receive more dose than prescribed
Details
- Recalling Firm
- Ion Beam Applications S.A.
- Units Affected
- 4 units
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of IL, VA, WA and the country of Germany.
- Location
- Louvain-la-neuve, N/A
Frequently Asked Questions
What product was recalled? ▼
Proteus235- Proton Therapy System: 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: 4 units.
Why was this product recalled? ▼
First layer of Uniform Scanning treatment fields is sometimes irradiated with incorrect Scanning Magnet setpoints resulting in the field size may be smaller than expected and the irradiated area may receive more dose than prescribed
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 8, 2022. Severity: Moderate. Recall number: Z-1205-2022.
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