RayStation/RayPlan 8B Service Pack 1, Build Number 8.1.1.8, stand-alone software treatment planning system

Recall Insight

This FDA Devices action (record #Z-1465-2020) was formally reported on March 18, 2020, with the manufacturer initiating the action on February 20, 2020. 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. Federal records indicate 1 system in the U.S. units are affected.

The documented reason for this recall is: There is a potential for erroneous propagation of the current tabletop positions when applying pitch or roll correction. Even though pitch and roll correction is never propagated, non-zero pitch or roll causes the later… Distribution data in the federal record shows the product reached: The products were distributed to the following US states: TN. 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 6 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.