Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

RayCare Recalled by RAYSEARCH LABORATORIES AB Due to When performing offline image review in RayCare 2C,...

Date: July 29, 2020
Company: RAYSEARCH LABORATORIES AB
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact RAYSEARCH LABORATORIES AB directly.

Affected Products

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.

Quantity: N/A

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About RAYSEARCH LABORATORIES AB

RAYSEARCH LABORATORIES AB has 113 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report