Z-0430-2014Class II

Dimension Vista(R) 500 and Dimension Vista(R) 1500 - Reloaded Vista Vials - limited to systems using software...

Name: Z-0430-2014 Dimension Vista(R) 500 and Dimension Vista(R) 1500 - Reloaded Vista Vials - limited to systems using software...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2013-05-20
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2013-05-20 / Terminated / root cause: software

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Dimension Vista(R) 500 and Dimension Vista(R) 1500 - Reloaded Vista Vials - limited to systems using software versions 3.4 and 3.5.1. Diagnostic device... on 2013-05-20. FDA classified it as Class II and gives the reason as "There is the potential for the vial volume of "in use" Vista calibrators, controls, or sample diluent to incorrectly revert to full volume when removed and reloaded. Dimension Vista(R) 500 and Dimension Vista(R) 1500 -...". 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-0430-2014
Classification: Class II
Status: Terminated
Initiated: 2013-05-20
Posted: 2013-12-02
Terminated: 2014-04-10
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Dimension Vista(R) 500 and Dimension Vista(R) 1500 - Reloaded Vista Vials - limited to systems using software versions 3.4 and 3.5.1. Diagnostic device intended to determine a variety of analytes in human body fluids.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: There is the potential for the vial volume of "in use" Vista calibrators, controls, or sample diluent to incorrectly revert to full volume when removed and reloaded. Dimension Vista(R) 500 and Dimension Vista(R) 1500 - Reloaded Vista Vials - limited to systems using software versions 3.4 and 3.5.1
Root cause tag: software
FDA root cause: Software design
Action: A notification letter was sent to consignees in May 2013.
Quantity in commerce: 776
Distribution: Worldwide Distribution: USA (nationwide) and iinternationally to Canada.
Product codes and lots: Dimension Vista(R) 500 - Siemens Material Number 10284473 and Dimension Vista(R) 1500 - Siemens Material Number 10444801

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0430-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0430-2014	Class II	Terminated	Voluntary: Firm initiated	2013-12-11	2013-12-02

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)