Leica Biosystems Imaging, Inc.: Medical Device Recall in 2019 - (Recall #: Z-0046-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

Aperio CS2 CE IVD scanner instrument, scanner part #23CS100CE.

Product Classification:

Class II

Date Initiated: December 10, 2018

Date Posted: October 16, 2019

Recall Number: Z-0046-2020

Event ID: 83383

Reason for Recall:

The incorrect sensor was used in the assembly of the camera in the scanner instrument which can potentially generate whole slide images that impact analysis algorithm results, as well as potentially impact the visual appearance of whole slide images.

Status: Terminated

Product Quantity: 3 devices

Code Information:

Serial numbers 5899, 5902, and 5986.

Distribution Pattern:

There was no U.S. distribution. Foreign distribution was made to South Korea and the United Kingdom.

Voluntary or Mandated:

Voluntary: Firm initiated