FDA recall Z-2899-2020

RAYSEARCH LABORATORIES AB · Class II · device

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.

Reason for recall

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.

Distribution

US Nationwide distribution including in the state of Tennessee.

Key facts

Status
Ongoing
Initiation date
2020-07-29
Report date
2020-09-02
Voluntary/Mandated
Voluntary: Firm initiated
Location
Stockholm, N/A, Sweden

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2899-2020