Digital Pathology System — Class II medical device recall Z-0469-2014
Terminated recall by Omnyx Llc, reported 2013-12-18. There is an issue associated with Digital Pathology System (DPS) Software, in which the annotation tools withi
| Recall number | Z-0469-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Omnyx Llc, Pittsburgh, PA, United States |
| Recall initiated | 2013-10-01 |
| Classified | 2013-12-09 |
| Reported by FDA | 2013-12-18 |
| Terminated | 2014-04-16 |
| Countries outside the US | CA, CH |
| Quantity | 2 |
| Reason classes | software |
| Model numbers | 1.1, K1600LH, OMN-1005056-1 |
Product
Digital Pathology System (DPS) Software version 1.1 The Omnyx" Integrated Digital Pathology system, which consists of a whole slide scanner and associated software applications, is a scanning, receiving, storing, managing, annotating and computer monitor viewing system for digital whole slide images. Omnyx" products are for in vitro diagnostic use for specific clinical applications, and are intended for research use only on other applications. Specific clinical use applications are indicated in separate clinical specific user guides supplied by Omnyx.
Reason for recall
There is an issue associated with Digital Pathology System (DPS) Software, in which the annotation tools within the DPS version 1.1 Image Viewer will display incorrect measurements and area calculations for a region of interest on a scanned slide, under certain conditions.
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-0469-2014. 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.