# FDA recall Z-2109-2018

> **Ion Beam Applications S.A.** · Class II · device recall initiated 2016-10-28.

## Product

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.

## Reason for recall

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

## Distribution

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.

## Key facts

- **Recall number:** Z-2109-2018
- **Recalling firm:** Ion Beam Applications S.A.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2016-10-28
- **Report date:** 2018-06-13
- **Termination date:** 2019-08-09

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Louvain La Neuve, N/A, Belgium

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2109-2018

## Citation

> AI Analytics. FDA recall Z-2109-2018. Retrieved 2026-06-08 from https://api.ai-analytics.org/recall/Z-2109-2018. Source: US FDA. Licensed CC0.

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