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Terminated

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

FDA Recall Z-0826-2022 · Posted None

Recalling FirmDiagnos Inc
Recall StatusTerminated
Product CodeNFJ
Date Initiated2022-01-11
Date Terminated2024-06-18
Product Quantity1

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.

Firm Action

On 01/11/22, a recall notice was emailed to the firm's customer who was informed to immediately cease using the affected software. The only version of software cleared for commercialization is CARA v1.2.1. The customer was asked to contact a quality management representative if they had questions or comments at 1-405-678-8882 ext. 235 or [email protected]

Root Cause

No Marketing Application

Distribution Pattern

US: CA

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K110869CARADiagnos, Inc. · 2011-07-14

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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