Carl Zeiss Meditec PLEX Elite 9000 OCT Device May Expose Users to Hazardous Voltage
Carl Zeiss Meditec recalls 155 PLEX Elite 9000 Swept-Source OCT devices due to potential hazardous voltage exposure when contacting metal parts near the up/down switch during use.
Use caution until it’s fixed
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.
Contact the company
What happened, in plain English
Carl Zeiss Meditec is recalling 155 specific models of the PLEX Elite 9000 Swept-Source OCT device because faulty design could expose users to hazardous voltage when touching metal parts around the up/down switch. This poses a risk of electric shock during normal operation. Read more at govinfonow.com/recall/69619-carl-zeiss-meditec-plex-elite-9000-oct-device-may-expose.
Source Summary by GovInfoNow · govinfonow.com/recall/69619-carl-zeiss-meditec-plex-elite-9000-oct-device-may-expose · Updated August 20, 2026 · FDA enforcement record: FDA #Z-0770-2020
Cite this page
“Carl Zeiss Meditec PLEX Elite 9000 OCT Device May Expose Users to Hazardous Voltage.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69619-carl-zeiss-meditec-plex-elite-9000-oct-device-may-expose. Based on FDA recall #Z-0770-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0770-2020%22&limit=1).
Why it’s dangerous
The device's design may allow hazardous voltage to be exposed when the operator touches metal components near the up/down switch during normal use. This could cause electric shock if the device is faulty.
Who’s affected
Ophthalmologists and medical professionals who use the PLEX Elite 9000 Swept-Source OCT device for eye imaging are most at risk. The recall affects specific serial numbers from PE9000-001 to PE9000-0158.
How to tell if you have this one
Check for serial numbers starting with PE9000-001 through PE9000-0158 on the device's label. The PLEX Elite 9000 Swept-Source OCT is used for detailed eye imaging in medical settings.
- Brand
Carl Zeiss Meditec- Category
Medical device
What to do — step by step
Check Device Serial Number
Look for the serial number on the device label to confirm if it's in the affected range (PE9000-001 to PE9000-0158).
Stop Using if Affected
If your device has a serial number in the affected range, stop using it immediately to avoid potential electric shock.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 12 states.
FDA 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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, Florida, Illinois, Iowa, Kentucky, Maryland, Massachusetts, Michigan, New York, Ohio, Pennsylvania, Texas.
Recall timeline
FDA terminated this recall 2.7 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0770-2020 (October 16, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0770-2020 to see it in context.
- Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.