BfArM - Federal Institute for Drugs and Medical Devices

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Product group ophthalmological technology
Reference 02995/10

The company Optovue, Inc. notified of a corrective action for the diagnostic system iVue100 due to a possible scanned eye identification error when using the CAM attachment. The manufacturer will exchange the joy stick base assembly and update the iVue application software.

Safety Notice for iVue100, Optovue , Download_VeroeffentlichtAm_EN PDF, 105KB, File does not meet accessibility standards