Z-0770-2020Class II

The PLEX Elite 9000, a Swept-Source OCT [SS-OCT] -

Name: Z-0770-2020 The PLEX Elite 9000, a Swept-Source OCT [SS-OCT] -
Creator: Carl Zeiss Meditec, Inc.
Published: 2018-10-16
License: https://open.fda.gov/license/

Carl Zeiss Meditec Inc / initiated 2018-10-16 / Terminated / root cause: design

FDA source

Carl Zeiss Meditec, Inc. began a recall of 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... on 2018-10-16. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0770-2020
Classification: Class II
Status: Terminated
Initiated: 2018-10-16
Posted: 2020-01-02
Terminated: 2021-06-11
Recalling firm: Carl Zeiss Meditec Inc
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.
Product code: OBO Tomography, Optical Coherence
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.
Root cause tag: design
FDA 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) with an electrical implant are more sensitive to electrostatic discharge and must avoid use of the system prior to the hardware update. To correct the issue, customers will be contacted by a representative to schedule a Field Service Engineer to perform a mandatory hardware update for their PLEX Elite 9000.
Quantity in commerce: 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.
Product codes and lots: OBO /HJO Serial Numbers: PE9000-001, PE9000-002, PE9000-003, PE9000-003,PE9000-004, PE9000-005, PE9000-006, PE9000-007, PE9000-008, PE9000-009, PE9000-0010, PE9000-0011, PE9000-0012, PE9000-0013, PE9000-0014, PE9000-0015, PE9000-0016, PE9000-0020, PE9000-0021, PE9000-0022, PE9000-0023, PE9000-0024, PE9000-0025, PE9000-0026, PE9000-0027, PE9000-0029, PE9000-0030, PE9000-0031, PE9000-0032, PE9000-0033, PE9000-0034, PE9000-0035, PE9000-0036, PE9000-0038, PE9000-0039, PE9000-0040, PE9000-0041, PE9000-0042, PE9000-0043, PE9000-0044, PE9000-0045, PE9000-0046, PE9000-0047, PE9000-0048, PE9000-0049, PE9000-0050, PE9000-0051, PE9000-0052, PE9000-0053, PE9000-0054, PE9000-0055, PE9000-0056, PE9000-0057, PE9000-0058, PE9000-0059, PE9000-0060, PE9000-0061, PE9000-0062, PE9000-0063, PE9000-0064, PE9000-0065, PE9000-0066, PE9000-0067, PE9000-0068, PE9000-0069, PE9000-0070, PE9000-0071, PE9000-0072, PE9000-0073, PE9000-0074, PE9000-0075, PE9000-0076, PE9000-0077, PE9000-0078, PE9000-0079, PE9000-0080, PE9000-0081, PE9000-0082, PE9000-0083, PE9000-0084, PE9000-0085, PE9000-0086, PE9000-0087, PE9000-0088, PE9000-0089, PE9000-0090, PE9000-0091, PE9000-0092, PE9000-0093, PE9000-0094, PE9000-0095, PE9000-0096, PE9000-0097, PE9000-0098, PE9000-0099, PE9000-0100, PE9000-0101, PE9000-0102, PE9000-0103, PE9000-0104, PE9000-0105, PE9000-0106, PE9000-0107, PE9000-0108, PE9000-0109, PE9000-0110, PE9000-0111, PE9000-0112, PE9000-0113, PE9000-0114, PE9000-0115, PE9000-0116, PE9000-0117, PE9000-0118, PE9000-0119, PE9000-0120, PE9000-0121, PE9000-0122, PE9000-0123, PE9000-0124, PE9000-0125, PE9000-0126, PE9000-0127, PE9000-0128, PE9000-0129, PE9000-0130, PE9000-0131, PE9000-0132, PE9000-0133, PE9000-0134, PE9000-0135, PE9000-0137, PE9000-0138, PE9000-0139, PE9000-0140, PE9000-0141, PE9000-0142, PE9000-0143, PE9000-0144, PE9000-0145, PE9000-0146, PE9000-0147, PE9000-0148, PE9000-0149, PE9000-0150, PE9000-0151, PE9000-0152, PE9000-0153, PE9000-0154, PE9000-0155, PE9000-0156, PE9000-0158

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0770-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0770-2020	Class II	Terminated	Voluntary: Firm initiated	2020-01-08	2020-01-02

Product code OBO

K161194Class IIPLEX Elite 9000 SS-OCTCarl Zeiss Meditec, Inc. / cleared 2016-10-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)