Aperio CS2 CE IVD scanner instrument — Class II medical device recall Z-0046-2020
Terminated recall by Leica Biosystems Imaging, Inc., reported 2019-10-16. The incorrect sensor was used in the assembly of the camera in the scanner instrument which can potentially ge
| Recall number | Z-0046-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Leica Biosystems Imaging, Inc., Vista, CA, United States |
| Recall initiated | 2018-12-10 |
| Classified | 2019-10-04 |
| Reported by FDA | 2019-10-16 |
| Terminated | 2021-04-28 |
| Countries outside the US | GB, KR |
| Quantity | 3 devices |
| Reason classes | software |
| Serial numbers | 5899, 5902, 5986 |
| Model numbers | 23CS100CE |
Product
Aperio CS2 CE IVD scanner instrument, scanner part #23CS100CE.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0046-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.