Ion Beam Applications S.A.: Medical Device Recall in 2018 - (Recall #: Z-2109-2018)

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:

12C (AdaPTinsight) Affected component: AdaPTinsight software Product Usage: 12C is used with a charged particle or photon radiation therapy system for localization of the patient position with respect to the therapy equipment and to provide correction feedback to the radiation therapy system.

Product Classification:

Class II

Date Initiated: October 28, 2016

Date Posted: June 13, 2018

Recall Number: Z-2109-2018

Event ID: 80219

Reason for Recall:

IBA is initiating this recall to address an issue identified with AdaPTinsight software and to reduce risk related to this problem.

Status: Terminated

Product Quantity: 5 units (12C)

Code Information:

Affected units: SAT.123, SAT.126, PAT.115, SAT.122 and SBF.101

Distribution Pattern:

Worldwide Distribution - US Nationwide in the states of LA, TX, Italy, Sweden and France. Each country's National Competent Authorities were notified of the firm's Field Safety Notice.

Voluntary or Mandated:

Voluntary: Firm initiated