The Recall Desk

Manufacturer

Diagnos Inc

1 recall in our database name Diagnos Inc as the manufacturing or recalling firm.

What the numbers show

Total
1
Critical
0
Severe
0
Most recent
2022-04-06

Of the 1 recalls from Diagnos Inc we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–1 of 1

  • HighFDA (Devices)·Z-0826-2022·2022-04-06

    Retinal Analysis Software with Potentially Unapproved AI Features Recalled

    Diagnos Inc is recalling CARA retinal analysis software version 4.7.2 because some AI-based features may lack appropriate FDA market approval. Users are advised to revert to a prior software version.

    Product
    CARA (Computer Assisted Retinal Analysis), Product ID: +B543CARA0/$$+7V4.7.2/16D202111179
    Category
    Medical Device
    Distribution
    1 state