Recall Z-0770-2020— Carl Zeiss Meditec, Inc.

Name: FDA recall Z-0770-2020
Creator: U.S. Food and Drug Administration
Published: 2018-10-16

Class II · Terminated

Class II FDA medical device recall by Carl Zeiss Meditec, Inc., initiated 2018-10-16, terminated 2021-06-11. It names one FDA 510(k) clearance: K161194. 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.. Reason: 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..

Recalling firm: Carl Zeiss Meditec, Inc.
Classification: Class II
Status: Terminated
Initiated: 2018-10-16
Terminated: 2021-06-11
Firm location: Dublin, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K161194 — PLEX Elite 9000 SS-OCTCarl Zeiss Meditec, Inc.·cleared 2016-10-26

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.