ViewRay System: Model No. 10000 and 20000 for radiation treatment. PN11440 MRIdian System Treatment Planning and Delivery System (TPDS) software

Recall Insight

This FDA Devices action (record #Z-1803-2020) was formally reported on May 6, 2020, with the manufacturer initiating the action on November 18, 2019. It is classified under Moderate severity (Class II), with a current status of Terminated. Viewray, Inc. is listed as the recalling firm, operating out of Mountain View, CA. Federal records indicate 32 units are affected.

The documented reason for this recall is: Registering dose and structures in the treatment delivery workflow could result in an alignment discrepancy between the imported previously delivered dose and the displayed patient anatomy and structures. The MRIdian TP… Distribution data in the federal record shows the product reached: Worldwide distribution. US states of MO, WI, CA, FL, MI, NY, MI, IL, and MA. South Korea, Netherlands, Italy, Japan, Germany, UAE, Turkey, France, Israel, Denmark, Switzerland, and United Kingdom. The distributo…. 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.