Recall – Treatment planning system may display unintentional error message

Company: RAYSEARCH LABORATORIES AB
Date of Enforcement Report: 9/2/2020
Class II

PRODUCT

RayCare, device is stand-alone software – Product Usage: used to support workflows and scheduling, as well as clinical information, planning and treatment management for oncology care.

Recall Number: Z-2899-2020

REASON

When performing offline image review in RayCare 2C, RayCare 3A and RayCare 3B an offline image review task will guide you to the image viewer with the treatment image related to the fraction and the planning image selected. When starting the task, an error message might be displayed stating: Review files not available.

RECALLING FIRM/MANUFACTURER

RAYSEARCH LABORATORIES AB on 7/29/2020. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

NA

DISTRIBUTION

U.S. Nationwide

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

Corporate Office

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