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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:150884

Merge Eye Station f/k/a: DFC-1024 & DFC-512 Digital Imaging System, WinStation, and WinStation Retinal Imager distributed by Ophthalmic Imaging Systems (OIS). Versions: 11.6.0 and prior

Official recall number

Z-1017-2017

Evidence summary

Product code
HKI
Recall status
Terminated
Event initiated
December 09, 2016
Root cause
Software design
Source snapshot
d51b4b87fdeb9ccf809d8b814d67f3a0fa43ac67bead6c171fe27284699c3275
Product
Z-1017-2017

Field note

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