Proteus 235-Proton Therapy System recall
Proteus 235-Proton Therapy System
Why was Proteus 235-Proton Therapy System recalled?
if the user forgets to select the trigger input manually while beam gating is prescribed for the patient, the proton irradiation will be delivered without gating. If the beam is not gated as prescribed, the treatment field may be delivered with an error in position
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?
Serial Numbers: PAT.107 (EU), PAT.108 (US), PAT.109 (US), PAT.115 (EU), SAT.117 (EU), SAT.118 (RU), SAT.119 (US), SAT.120 (EU), SAT.122 (EU), SAT.125 (IN), SAT.126 (US), SAT.132 (EU), SAT.133 (US).
- Product
- Proteus 235-Proton Therapy System
- Recalling firm
- Ion Beam Applications S.A.
- Quantity
- 5 US; 8 OUS
- Distribution
- FL, PA, TN, TX, VA Foreign: Germany, Italy, Russia, Sweden , India, Netherlands
- Recall date
- August 4, 2021
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)