Oncentra Brachy users using version 4.0 and above with Applicator Modeling license 170283-00

Recall Insight

This FDA Devices action (record #Z-0182-2022) was formally reported on November 3, 2021, with the manufacturer initiating the action on October 13, 2021. It is classified under Moderate severity (Class II), with a current status of Ongoing. Elekta, Inc. is listed as the recalling firm, operating out of Atlanta, GA. Federal records indicate 1072 devices units are affected.

The documented reason for this recall is: Under certain circumstances, there can be a difference between the planned and delivered dose of the two ovoid channels. Distribution data in the federal record shows the product reached: Distribution throughout USA OUS distribution including:Algeria, Argentina, Australia, Austria Bahamas, Bangladesh, Belarus, Belgium, Bolivia, Botswana, Brazil Brunei, Bulgaria, Canada, Chile, China, Colombia, Croatia, …. 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 5 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.