Recall Z-2280-2023 ยท PSY Whole Slide Imaging System
Hamamatsu Corporation
NanoZoomer S360MD Slide scanner system-automated system for creating, viewing, and managing digital slides. The NanoZoomer System creates diagnostic-quality digital images of glass slides containing formalin-fixed paraffin-embedded (FFPE) tissue. Catalog Number: C13220-01MD
| Date | Aug 1, 2023 (initiated Jun 6, 2023) |
| Status | Open, Classified |
| Reason | If the wrong barcode information is recorded in the NDPi file, a pathologist may refer to the whole slide image (WSI) of a different patient. |
| Root cause | Software design |
| Action | Hamamatsu Corporation issued Urgent: Medical Device Correction Letter via Email on 6/6/23. Letter states reason for recall, health risk and action to take: The risk of recurrence will be fully eliminated by conducting the NZAcquire software update on the user PCs either by a Field Service Engineer being on site or via a remote control. As a precautionary measure, there are two kinds of risk mitigations in place to reduce the potential serious risk. 1. There is a clear note in the NZAcquireMD Reference manual regarding the barcode information. 2. There is a warning in the system manual that th |
| Quantity | 1 unit |
| Distribution | NY |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K213883 | NanoZoomer S360MD Slide scanner system Hamamatsu Photonics K.K., Sep 27, 2022 |