Reported Jun 20, 2018 · Terminated
Proteus ONE and Proteus Plus
Ion Beam Applications S.A.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ion Beam Applications S.A. · Chemin du Cyclotron, 3 · Louvain La Neuve, N/A · N/A
Is this the product you have?
- Proteus ONE and Proteus Plus
- Lot codes and dates
- Code/Serial Numbers
PAT.000PAT.003PAT.006PAT.107PAT.108PAT.109PAT.110PAT.111PAT.112PAT.113PAT.114PAT.115SAT.116SAT.117SAT.119SAT.120SAT.122SAT.123SAT.126SBF.101
- Code/Serial Numbers
- Amount recalled
- N/A
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Why it was recalled
IBA is initiating this recall to notify its customers that the use of non-IBA accessories and/or third party equipment or unauthorized modifications to an IBA medical device may pose a safety risk.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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