Recall Z-0046-2020 ยท NOT Microscope, Automated, Image Analysis, Operator Intervention
Leica Biosystems Imaging, Inc.
Aperio CS2 CE IVD scanner instrument, scanner part #23CS100CE.
| Date | Oct 4, 2019 (initiated Dec 10, 2018) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K141109 | APERIO EPATHOLOGY EIHC IVD SYSTEM Leica Biosystems Imaging, Inc., Jul 29, 2014 |