navify Digital Pathology Software Recall

The full picture behind this FDA recall

This notice was issued by FDA on August 25, 2026 and geographically references United States. The FDA classifies this as a Class II recall, with the stated reason "Due to complaints received for the Image Management System regarding image/metadata discrepancy with the Viewer window", distributed worldwide - u.s. nationwide distribution including in the states of al, ar, az, ca, co, ct, fl, ga, ia, id il, in, ks, ky, ma, md, mi, mn, mo, ms, nc, nj, ny, oh, ok, pa, pr, sc, sd, tn, tx, ut, wi, and wv. the countries of austria, belgium, czech republic, france, germany, ireland, italy, netherlands, romania, spain, and switzerland, argentina, bosnia & herzegovina, brazil, chile, colombia, dominican republic, ecuador, jordan, mexico, myanmar, peru, turkey, united kingdom, australia, bahrain, colombia, hong kong, portugal and india.. FDA recall classes run from I (reasonable probability of serious harm) to III (unlikely to cause harm), so the class number is the fastest way to gauge severity here. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.

A quick skim tells you whether this affects you directly; a closer read tells you more. Check the scope, the source, and how recent the record is, then weigh it against related notices rather than treating any single one as a trend.

The original agency source is linked below so you can verify this record directly before acting on it. Its related labels are recall, product-safety, fda, Devices.