Proteus 235 Proton Therapy System Legacy Software recall
Proteus 235 Proton Therapy System Legacy Software version 7.2.7 and higher, models 110, 112, 113, and 116. Proton therapy
Why was Proteus 235 Proton Therapy System Legacy Software recalled?
Internal testing of the Proteus 235 Proton Therapy System revealed incorrect dose rate calculation in case of beam line option other than Zero (0).
What should I do if I have this product?
Review the official FDA enforcement record for current 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?
Proteus 235 Proton Therapy System Legacy Software version 7.2.7 and higher, models 110, 112, 113, and 116.
- Product
- Proteus 235 Proton Therapy System Legacy Software version 7.2.7 and higher, models 110, 112, 113, and 116. Proton therapy
- Recalling firm
- Ion Beam Applications S.A.
- Quantity
- 4
- Distribution
- US Distribution including the states of OK, IL, NJ, and WA.
- Recall date
- April 30, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)