Proteus235- Proton Therapy System: to produce and recall
Proteus235- Proton Therapy System: to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions…
Why was Proteus235- Proton Therapy System: to produce and 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
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI: (01)05404013801138 Serial Numbers: PAT108 (US), PAT112 (US), SAT116 (US). PAT107 (EU).
- Product
- Proteus235- Proton Therapy System: to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions…
- Recalling firm
- Ion Beam Applications S.A.
- Quantity
- 4 units
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of IL, VA, WA and the country of Germany.
- Recall date
- June 8, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)