Z-1454-2012

Siemens Healthcare Diagnostics Dimension Vista(R) software version 3.4 The Dimension Vista(R) System is an in...

Name: Z-1454-2012 Siemens Healthcare Diagnostics Dimension Vista(R) software version 3.4 The Dimension Vista(R) System is an in...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2012-01-16
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2012-01-16 / Terminated / root cause: software

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Siemens Healthcare Diagnostics Dimension Vista(R) software version 3.4 The Dimension Vista(R) System is an in vitro diagnostic device intended to duplicate... on 2012-01-16. The reason FDA records is "Siemens has confirmed customer complaints on Vista(R) software version 3.4 for Below Manufacturer Assay Range error flags associated with QC and patient test results that are within the assay range as defined in the...". 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-1454-2012
Status: Terminated
Initiated: 2012-01-16
Posted: 2012-04-25
Terminated: 2014-03-05
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Siemens Healthcare Diagnostics Dimension Vista(R) software version 3.4 The Dimension Vista(R) System is an in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluids. Dimension Vista(R) chemical and immunochemical applications use photometric, turbidimetric, chemiluminescence, nephelometric and integrated ion-selective multisensory technology for clinical use.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: Siemens has confirmed customer complaints on Vista(R) software version 3.4 for Below Manufacturer Assay Range error flags associated with QC and patient test results that are within the assay range as defined in the Instructions For Use for the respective method. This issue is isolated to Vista(R) software version 3.4. Customers who have not made any changes to the default method configurations
Root cause tag: software
FDA root cause: Software change control
Action: Siemens sent an Urgent Field Safety Notice dated December 19, 2011 to all affected customers alerting them to Invalid Below Manufacturer Assay Range Flags on Dimension Vista(R) Systems with Software Version 3.4. The UFSN included instructions on how to correct the situation and also included an effectiveness check form to be faxed to the firm at 302-631-8467. On January 16, 2012, the firm issued an additional UFSN alerting consignees to Invalid Above and Below Manufacturer Assay Range Flags. This notice also included directions and a Field Correction Effectiveness Check form to be completed and faxed to 302-631-8467. For technical questions customers were instruced to call 800-441-9250. For questions regarding this recall call 302-631-6299.
Quantity in commerce: 1,683
Distribution: Worldwide Distribution - USA (nationwide) and the countries of Australia, Austria, Belgium, Canada, Czech Republic, Denmark, Finland & Baltics, France, Germany, Italy, Japan, South Korea, Malaysia, Netherlands, New Zealand, Norway, Portugal, Puerto Rico, Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Switzerland and United Kingdom.
Product codes and lots: Vista software version 3.4

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)