Siemens Healthcare Diagnostics Dimension Vista Systems — Class II medical device recall Z-2054-2015
Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2015-07-15, distributed nationwide. Two software issues may occur in Vista software version 3.6.1. Issue #1: Samples may stop processing without n
| Recall number | Z-2054-2015 |
|---|---|
| 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 | 2015-05-21 |
| Classified | 2015-07-09 |
| Reported by FDA | 2015-07-15 |
| Terminated | 2017-03-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, CA, CH, CZ, DE, DK, ES, FI, FR, GB, IT, JP, KR, NL, NO, NZ, PT, SA, SI, SK |
| Quantity | 2,315 |
| Reason classes | potency, software |
Product
Siemens Healthcare Diagnostics Dimension Vista Systems, used with the Dimension Vista Intelligent Lab System software version 3.6.1. In vitro diagnostic analyzer.
Reason for recall
Two software issues may occur in Vista software version 3.6.1. Issue #1: Samples may stop processing without notification. Issue #2: Timing issue in Vista 1500 may cause wrong reagent or no reagent delivery. This may lead to unflagged, unexpected low results and results flagged with assay errors.
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-2054-2015. 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.