syngo Lab Data Manager System — Class II medical device recall Z-1195-2019
Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2019-04-24, distributed nationwide. Software Issues.
| Recall number | Z-1195-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Inc., Newark, DE, United States |
| Recall initiated | 2015-08-26 |
| Classified | 2019-04-18 |
| Reported by FDA | 2019-04-24 |
| Terminated | 2020-03-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | BE, BS, DE, FR, GB, IT, JP, MX, SK |
| Quantity | 449 systems |
| Reason classes | software |
| Model numbers | 10624077, 10638933, 10804573, 510K |
Product
syngo Lab Data Manager System - Product Usage: syngo Lab Data Manager is a clinical system that assists medical laboratory professions with pre-analytic and post-analytic functions. It works in conjunction with multiple instruments, the laboratory information system (LIS) and the Siemens Healthcare Diagnostics Data Center. It supports the Siemens analyzers through delivery of applications and connectivity features.
Reason for recall
Software Issues.
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-1195-2019. 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.