Carl Zeiss Meditec, Inc.: Medical Device Recall in 2020 - (Recall #: Z-0770-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: October 16, 2018

Date Posted: January 8, 2020

Recall Number: Z-0770-2020

Event ID: 83229

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.

Status: Terminated

Product Quantity: 151 devices

Code Information:

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

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated