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Recall Observatory FDA recall evidence

Device product

Proteus ONE and Proteus Plus

Z-2139-2018

September 16, 2016

Class II

Product summary

Firm
Ion Beam Applications S.A.
Event
Event 80221
Status
Terminated
Classification
Class II
Quantity
N/A
Official record key
device-enforcement:Z-2139-2018

Official wording

Reason: 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.

Code information: 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

Distribution pattern: Units were delivered in the USA, Korea, Germany, France, Czech Republic, Italy, Poland and Sweden.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.