Reported Jan 8, 2020 · Terminated
The PLEX Elite 9000, a Swept-Source OCT [SS-OCT] - Product Usage: The PLEX Elite 9000 Swept-Source OCT [SS-OCT] is a…
Carl Zeiss Meditec, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Carl Zeiss Meditec, Inc. · 5160 Hacienda Dr · Dublin, CA · 94568-7562
Is this the product you have?
- The PLEX Elite 9000, a Swept-Source OCT [SS-OCT] -
- Product UsageThe 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
- Lot codes and dates
- OBO /HJO Serial Numbers
152 of 152 codes
PE9000-001PE9000-002PE9000-003PE9000-003PE9000-004PE9000-005PE9000-006PE9000-007PE9000-008PE9000-009PE9000-0010PE9000-0011PE9000-0012PE9000-0013PE9000-0014PE9000-0015PE9000-0016PE9000-0020PE9000-0021PE9000-0022PE9000-0023PE9000-0024PE9000-0025PE9000-0026PE9000-0027PE9000-0029PE9000-0030PE9000-0031PE9000-0032PE9000-0033PE9000-0034PE9000-0035PE9000-0036PE9000-0038PE9000-0039PE9000-0040PE9000-0041PE9000-0042PE9000-0043PE9000-0044PE9000-0045PE9000-0046PE9000-0047PE9000-0048PE9000-0049PE9000-0050PE9000-0051PE9000-0052PE9000-0053PE9000-0054PE9000-0055PE9000-0056PE9000-0057PE9000-0058PE9000-0059PE9000-0060PE9000-0061PE9000-0062PE9000-0063PE9000-0064
- OBO /HJO Serial Numbers
- Amount recalled
- 151 devices
Where it was sold
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.
This product could cause temporary or reversible health problems — stop using it.
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