FDAFDA · Food and drugs·Recall number Z-2139-2018
Proteus ONE and Proteus Plus
Published June 20, 2018 · Recall initiated: September 16, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Ion Beam Applications S.A.
- Distributor
- Units were delivered in the USA, Korea, Germany, France, Czech Republic, Italy, Poland and Sweden.
- Lot
- Code/Serial Numbers: PAT.000, PAT.003, PAT.006, PAT.107, PAT.108, PAT.109, PAT.110, PAT.111, PAT.112, PAT.113, PAT.114, PAT.115, SAT.116, SAT.117, SAT.119, SAT.120, SAT.122, SAT.123, SAT.126, SBF.101
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Belgium
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