Class III — Low Risk

Low risk — use of or exposure to this product is not likely to cause adverse health consequences.

CytoVision Image Analysis and Capture System Recalled by Leica Biosystems Richmond Inc. Due to Systems have an improperly activated Windows 7 OS,...

Date: May 2, 2016
Company: Leica Biosystems Richmond Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Leica Biosystems Richmond Inc. directly.

Affected Products

CytoVision Image Analysis and Capture System, an automated cell-locating device. The Cytovision is a rapid metaphase finder, image acquisition and computer aided chromosome analysis system which assists the operator in viewing chromosomes and looking for cellular anomalies. CytoVision enables a qualified Cytogeneticist to rapidly and accurately analyze the chromosome banding pattern.

Quantity: 283 systems

Why Was This Recalled?

Systems have an improperly activated Windows 7 OS, even though a valid Windows 7 license was associated with each manufactured system. The system appears to be unlicensed. These systems cannot be re-activated using standard Windows licensing procedures and are requiring checks of each potentially affected system to confirm Windows 7 OS is properly activated.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Leica Biosystems Richmond Inc.

Leica Biosystems Richmond Inc. has 9 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report