FDA Medical Device Recalls (openFDA)
Leica Biosystems Imaging, Inc.: Aperio CS2 CE IVD scanner instrument, scanner part #23CS100CE.
- Recall number
- Z-0046-2020
- Recalling firm
- Leica Biosystems Imaging, Inc.
- Product
- Aperio CS2 CE IVD scanner instrument, scanner part #23CS100CE.
- Status
- Terminated
- Initiated
- 2018-12-10
- Posted
- 2019-10-04
- Terminated
- 2021-04-28
- 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.
- Root cause
- Component design/selection
- Action
- The consignees were notified beginning on 12/10/2018 via letter delivered by email.
- Quantity
- 3 devices
- Distribution
- There was no U.S. distribution. Foreign distribution was made to South Korea and the United Kingdom.
- Lot, serial or model codes
- Serial numbers 5899, 5902, and 5986.
- 510(k) numbers
- ["K141109"]
- PMA numbers
- not on file
- Product code
- NOT
- Firm FEI
- 3006791373
- Firm city
- Vista
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28