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Recall Observatory FDA recall evidence

Derived label

Device software or design

Pentacam AXL REF 70100, Pentacam HR REF 70900. Used to image the anterior segment of the eye.

reason.device_software_design

v1.0.0

Assignment summary

Mode key
device_software_design
Evidence excerpt
software issue
Rule explanation
Device recall wording explicitly identifies a software, firmware, programming, cybersecurity, or design defect and its failure or consequence.
Firm
Oculus Optikgeraete GMBH

Field note

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