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Recall Observatory FDA recall evidence

Device product

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

Z-0046-2020

December 10, 2018

Class II

Product summary

Firm
Leica Biosystems Imaging, Inc.
Event
Event 83383
Status
Terminated
Classification
Class II
Quantity
3 devices
Official record key
device-enforcement:Z-0046-2020

Official wording

Reason: 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.

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.