AdaPTinsight software: Cl II

Company:Ion Beam Applications S.A..
Date of Enforcement Report 6/13/2018
Class lI:

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.
Recall Number: Z-2109-2018

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

RECALLING FIRM/MANUFACTURER
Ion Beam Applications S.A., Louvain La Neuve, Belgium on 10/28/2016. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
5 units (12C)

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.

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About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

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15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.