Device recall

Z-1193-2025: Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning…

FDA device recall · Class II · RAYSEARCH LABORATORIES AB

Key facts

Recall number (Z-number) Z-1193-2025
Recall event 96156
Product Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 6.0.0.24 Software Version: RayStation 6
Product code MUJ
Recalling firm RAYSEARCH LABORATORIES AB
Recall class Class II
Status Open, Classified
510(k) numbers K170355
FEI number 3007774465

At a glance

  • 1–9 Linked 510(k)s
  • 10–99 Products in the same recall event
  • 100–999 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

Browse all FDA device recalls (products)