Ion Beam Applications S.A.: Medical Device Recall in 2018 - (Recall #: Z-2139-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

Proteus ONE and Proteus Plus

Product Classification:

Class II

Date Initiated: September 16, 2016

Date Posted: June 20, 2018

Recall Number: Z-2139-2018

Event ID: 80221

Reason for Recall:

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.

Status: Terminated

Product Quantity: N/A

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.

Voluntary or Mandated:

Voluntary: Firm initiated