Carl Zeiss Meditec CIRRUS HD-OCT, Models 5000 AngioPlex and 6000 AngioPlex recall — FDA Z-0723-2022
Optic nerve head angiography scan to be turned off due to its distribution without pre-market clearance.
Overview of recall records associated with Carl Zeiss Meditec, Inc., including dates, categories and classifications where available.
Classification mix: Class II: 4.
Optic nerve head angiography scan to be turned off due to its distribution without pre-market clearance.
Due to failure to acquire pre-market clearance for its high resolution tomographic/biomicroscope imaging device (Model 6000) prior to commercializing the device.
Under certain fault conditions, the existing design may expose the operator to a hazardous voltage when contacting the metal enclosure (including mounting screws) around the up/down switch.
VisuMax devices with software version 2.10.13 and activated SW-Module ReLEx (SMILE) option may experience a software issue. In case of a suction loss during treatment the software allows…
This page summarizes recall records in which the official source identifies Carl Zeiss Meditec, Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.