Class II — Siemens Healthcare Diagnostics, Inc.
| Recalling firm | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
|---|---|
| Registered facility | View this company's 12 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| Product | Siemens Healthcare Diagnostics Dimension Vista Systems, used with the Dimension Vista Intelligent Lab System software version 3.6.1. In vitro diagnostic analyzer. |
| Quantity | 2315 |
| Distribution | Worldwide Distribution - Nationwide Distribution including Puerto Rico., and the countries of : Austria, Australia, Belgium, Canada, Denmark, France, Finland, Germany, Japan, Italy, New Zealand, Netherlands, Czech Republic, Portugal, Republic Korea, Norway, Spain, Switzerland, Slovakia, Saudi Arabia, Slovenia, and United Kingdom, |
| Initiated | 2015-05-21 |
| Classified | 2015-07-09 |
| Terminated | 2017-03-10 |
| Recall number | Z-2054-2015 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Siemens Healthcare Diagnostics, Inc. (Z-2054-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/71315/
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