Proteus 235 recall
Proteus 235, Universal Nozzle with snout 300x400; PBS dedicated nozzle with snout XL Product Usage: Device is designed to produce and deliver proton…
Why was Proteus 235 recalled?
Gantry rotation or proton irradiation can be allowed even if apertures or accessories are not correctly positioned in snout 300x400 or snout XL. This can lead to risk of crushing for patient and/or user, and risk of mistreatment for the patient.
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?
PAT.003, PAT.006, PAT.107, PAT.108, PAT.109, PAT.110, PAT.111, PAT.113, PAT.114, PAT.115, PAT.116, PAT.120, PAT.126, and PAT.132.
- Product
- Proteus 235, Universal Nozzle with snout 300x400; PBS dedicated nozzle with snout XL Product Usage: Device is designed to produce and deliver proton…
- Recalling firm
- Ion Beam Applications S.A.
- Quantity
- 14
- Distribution
- US Nationwide Distribution in the states of FL, VA, PA, OK, NJ, WA, and TX.
- Recall date
- July 25, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)