Product Safety Recalls

Product Recall Tracker

Diagnos Inc Recall 89715

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

Diagnos Inc Recall 89715 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0826-2022
Event ID89715
Event DescriptionCARA (Computer Assisted Retinal Analysis), Product ID: +B543CARA0/$$+7V4.7.2/16D202111179
Product TypeDevices
DistributionUS: CA
Quantity1
Recall ReasonRetinal 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.
Device Classification20220406
Device Code InfoSoftware Version 4.7.2
Center Classification Date20220325
Recall Initiation Date20220111
Recalling FirmDiagnos Inc
Initial Notification Letter
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