Recall Z-2109-2018— Ion Beam Applications S.A.
Class II · Terminated
Class II FDA medical device recall by Ion Beam Applications S.A., initiated 2016-10-28, terminated 2019-08-09. It names one FDA 510(k) clearance: K132847. 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: IBA is initiating this recall to address an issue identified with AdaPTinsight software and to reduce risk related to this problem..
- Recalling firm
- Ion Beam Applications S.A.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-10-28
- Terminated
- 2019-08-09
- Firm location
- Louvain La Neuve, N/A, Belgium
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Reason for recall
IBA is initiating this recall to address an issue identified with AdaPTinsight software and to reduce risk related to this problem.
Data sourced from openFDA. This site is unofficial and independent of the FDA.