CIRRUS HD-OCT 6000Recalls & reported problems

Carl Zeiss Meditec, Inc. · The CIRRUS HD-OCT is a non-contact, high resolution tomographic and biomicroscopic imagining device intended for in-vivo viewing, axial cross-sectional, and three-dimensional imagining of anterior and posterior ocular structures. · Class 2

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04057748087141), received between Apr 4, 2023 and Apr 4, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Unintended Electrical Shock” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Device problems

Unintended Electrical Shock1

Patient problems

No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

MalfunctionApr 4, 2023Unintended Electrical Shock; Unintended Electrical Shock
ON (B)(6) 2023, CZMI BECAME AWARE THAT ON (B)(6) 2023, A USER IN GERMANY HAD RECEIVED AN ALLEGED ELECTRIC SHOCK WHILE OPERATING THE CIRRUS 6000 POWER TABLE. IT WAS COMMUNICATED THAT UPON RECEIVING THE SHOCK, THE USER BRIEFLY HAD A PAIN IN HER FINGER AND FOR THE REST OF THE DAY THERE WAS A TINGLING IN HER FINGERTIP. THERE WAS NO INJURY REPORTED AND NO MEDICAL INTERVENTION PERFORMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16678757 ↗

Device details

UDI-DI	`04057748087141`
Brand	CIRRUS HD-OCT
Model	6000
Company	Carl Zeiss Meditec, Inc.
Product code	OBO · Tomography, Optical Coherence
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Jun 5, 2020

Device type (GMDN): Ophthalmic spectral-domain optical coherence tomography system

A mobile assembly of devices designed to use near infrared (NIR) LED light aimed into the eye to acquire, process, display and save in vivo depth-resolved images of anterior and posterior ocular tissue microstructures in clinical and perioperative examination through the use of interchangeable lenses. Spectral domain optical coherence tomography (SDOCT) is intended to aid in the diagnosis and evaluation of physiologic and pathologic conditions of the eye through non-contact optical imaging. Reflected light is picked up by a detector that converts it into electrical signals using a computer and dedicated software, providing cross-sectional or three-dimensional (3-D) volume scans for analysis.

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Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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