Recall record at a glance
| Official record | Z-2173-2018 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Ion Beam Applications S.A. |
| Report date | Jun 20, 2018 |
| Recall initiation date | Aug 7, 2016 |
| Quantity | 19 units |
| Location | Louvain La Neuve, N/A, Belgium |
Official product description
Proteus 235 The PTS is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. The PTS may include a fixed small beam treatment room dedicated to the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation localized to the head and neck.
Why the product was recalled
IBA is recalling to provide information through a Safety Notice to reduce risk for maintenance technicians during ion source replacement.
Distribution information
Units were distributed in the USA, Korea, Germany, France, Czech Republic, Italy, Poland, and Sweden. Each country's national Competent Authorities have been informed.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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