Z-2054-2015Class II

Siemens Healthcare Diagnostics Dimension Vista Systems, used with the Dimension Vista Intelligent Lab System...

Name: Z-2054-2015 Siemens Healthcare Diagnostics Dimension Vista Systems, used with the Dimension Vista Intelligent Lab System...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2015-05-21
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2015-05-21 / Terminated / root cause: software

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Siemens Healthcare Diagnostics Dimension Vista Systems, used with the Dimension Vista Intelligent Lab System software version 3.6.1. In vitro diagnostic... on 2015-05-21. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2054-2015
Classification: Class II
Status: Terminated
Initiated: 2015-05-21
Posted: 2015-07-09
Terminated: 2017-03-10
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Siemens Healthcare Diagnostics Dimension Vista Systems, used with the Dimension Vista Intelligent Lab System software version 3.6.1. In vitro diagnostic analyzer.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
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.
Root cause tag: software
FDA root cause: Software design (manufacturing process)
Action: Siemens sent an Urgent Medical Device Correction letter dated May 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Actions to be Taken by the Customer: For the corresponding issues listed above, please perform the following: Issue 1: If you experience this situation, sample processing can be resumed using the step(s) below: Step 1: From the Operation Icon select PAUSE, then immediately return to the Operation Icon and select Cancel PAUSE. Sample aliquotting should immediately resume. Step 2: If sample processing does not resume after Step 1, wait until the instrument displays System Ready, then restart the system software per the Vista Operator Guide, Section 2, Controlled Shutdown-Restart procedure. Issue 2: To prevent the Reagent Servers from temporarily losing synchronization, Siemens recommends setting the Auto Dispose option to No for methods assigned to Reagent Server 2 (see instructions below). These empty or expired reagent cartridges will now remain on the instrument and require the operator to unload them. Please consult your Vista Operators Guide or method Instructions for Use when results with flags and/or errors occur. We apologize for the inconvenience this situation may cause. If you have any questions, please contact your Siemens Customer Care Center-Technical Solutions at (800) 441-9250 or your local Siemens technical support representative.
Quantity in commerce: 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,
Product codes and lots: Siemens Material Number (SMN): 10284473, 10488224, 10444801, 10444802

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2054-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2054-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-15	2015-07-09

Product code JJE

K051087Class IDimension Vista Integrated SystemDade Behring, Inc. / cleared 2005-07-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)