Diagnos Inc: Medical Device Recall in 2022 - (Recall #: Z-0826-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

CARA (Computer Assisted Retinal Analysis), Product ID: +B543CARA0/$$+7V4.7.2/16D202111179

Product Classification:

Class II

Date Initiated: January 11, 2022

Date Posted: April 6, 2022

Recall Number: Z-0826-2022

Event ID: 89715

Reason for Recall:

Retinal analysis system software has some features, based on artificial intelligence, that potentially lack appropriate market approval, so it is recommended to use a specific prior software version.

Status: Terminated

Product Quantity: 1

Code Information:

Software Version 4.7.2

Distribution Pattern:

US: CA

Voluntary or Mandated:

Voluntary: Firm initiated