Recall Z-0770-2020 ยท OBO Tomography, Optical Coherence
Carl Zeiss Meditec, Inc.
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 incl
| Date | Oct 16, 2018 |
| Status | Terminated |
| 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. |
| Root cause | Device Design |
| Action | Recalling Firm issued Urgent Medical Device Recall notices to all customers dated October 16, 2018. Customers were advised to take the following actions: Until the mandatory hardware update has been performed, follow the procedure below to continue the use of the PLEX Elite 9000: When adjusting the height of the Power Table, touch only the black plastic portion of the Up/Down switch. Avoid any contact with the entire metal enclosure (including mounting screws) surrounding the black plastic Up/Down switch. Failure to follow this procedure may result in potential injury. CAUTION: Operator(s) |
| Quantity | 151 devices |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K161194 | PLEX Elite 9000 SS-OCT Carl Zeiss Meditec, Inc., Oct 26, 2016 |