RayStation 9B SP1. For radiation treatment planning.

Recall Insight

This FDA Devices action (record #Z-1403-2022) was formally reported on July 27, 2022, with the manufacturer initiating the action on June 1, 2022. It is classified under Moderate severity (Class II), with a current status of Terminated. RAYSEARCH LABORATORIES AB is listed as the recalling firm, operating out of Stockholm, N/A. Federal records indicate 1 units are affected.

The documented reason for this recall is: An issue with propagation of treatment course information from RayStation with RayTreat to RayCare has been identified. During some workflows, information may not be propagated to RayCare. Distribution data in the federal record shows the product reached: Worldwide distribution - US Nationwide distribution in the state of TN and the countries of Belgium and Switzerland.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 4 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.