FDA-reported recall: imaging model flagged for distribution-shift errors in pediatric scans

Summary

The FDA published a Class II recall for an FDA-cleared AI-assisted radiology product after the manufacturer disclosed that the model's performance on pediatric scans had drifted outside the cleared performance envelope. The manufacturer issued a voluntary recall and software update. No patient harm has been formally attributed in the recall notice; the agency notes the recall is precautionary.

Sources

1. 01
   FDA — Class II recall notice, FDA Z-1845-2026

   primary5/7/2026