Carl Zeiss Meditec, Inc. recalls The PLEX Elite 9000, a Swept-Source OCT [SS-OCT] - Product Usage: The PLEX Elite 9000 Swept-Source OCT [SS-OCT] is a no

Recalled January 8, 2020 · FDA recall Z-0770-2020 · Carl Zeiss Meditec

Hazard

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. · FDA Class II

Units

151 devices

Sold at

Worldwide distribution - US Nationwide distribution in the states of CA, TX, NY, MA, OH, PA, IA, , KY, FL, MI, IL, MD and Germany, Japan, Switzerland, France Italy, Australia, Austria, Korea, China, India, Canada, Singapore, Norway, Taiwan, Israel, UAE.

Description

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.

Product

The PLEX Elite 9000, a Swept-Source OCT [SS-OCT] - Product Usage: The PLEX Elite 9000 Swept-Source OCT [SS-OCT] is a non- contact, high resolution, wide field of view tomographic and biomicroscopic imaging device intended for in-vivo viewing, axial cross-sectional and three-dimensional imaging of posterior ocular structures. The device is indicated for visualizing posterior ocular structures including, but not limited to, retina, retinal nerve fiber layer, ganglion cell plus inner plexiform layer, macula, optic nerve head, vitreous and choroid. The PLEX Elite SS-OCT angiography is indicated as an aid in the visualization of vascular structures of the retina and choroid.

Manufacturer(s)

Carl Zeiss Meditec, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →