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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:195360

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

Official recall number

Z-1673-2022

Evidence summary

Product code
MXK
Recall status
Open, Classified
Event initiated
July 08, 2022
Root cause
Software design
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-1673-2022