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…

Recall date

October 16, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0770-2020

FDA classification

Class II

Brand / firm

Carl Zeiss Meditec, Inc.

Sold / distributed

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.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.