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The PLEX Elite 9000, a Swept-Source OCT [SS-OCT] - Product Usage: The PLEX Elite 9000 Swept-Sour...

FDA Device Recall #Z-0770-2020 — Class II — October 16, 2018

Recall Summary

Recall Number Z-0770-2020
Classification Class II — Moderate risk
Date Initiated October 16, 2018
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Carl Zeiss Meditec, Inc.
Location Dublin, CA
Product Type Devices
Quantity 151 devices

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.

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.

Lot / 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

Other Recalls from Carl Zeiss Meditec, Inc.

Recall # Classification Product Date
Z-0723-2022 Class II CIRRUS HD-OCT, Models 5000 AngioPlex and 6000 A... Jan 14, 2022
Z-2227-2021 Class II Chassis Label - "CIRRUS HD-OCT Rx-Only" Prod... Jul 8, 2021
Z-0680-2020 Class II VisuMax Software Version 2.10.13 with activated... Dec 6, 2018
Z-0334-2014 Class II Zeiss brand IOLMaster 500, Model 500, Biomicros... Oct 23, 2013
Z-0333-2014 Class II Zeiss brand IOLMaster, Version 1-5, Biomicrosco... Oct 23, 2013

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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