Z-2088-2013Class II

Dimension Vista 500 and Dimension Vista 1500 System Aliquot Well Double Dispense with software versions 3.5.1...

Name: Z-2088-2013 Dimension Vista 500 and Dimension Vista 1500 System Aliquot Well Double Dispense with software versions 3.5.1...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2013-06-19
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2013-06-19 / Terminated / root cause: software

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Dimension Vista 500 and Dimension Vista 1500 System Aliquot Well Double Dispense with software versions 3.5.1 and 3.6. In vitro diagnostic device intended to... on 2013-06-19. FDA classified it as Class II and gives the reason as "Siemens is conducting a field correction for Dimension Vista 500 and Dimension Vista 1500 systems using software versions 3.5.1 and 3.6. Under specific rare conditions which require a system reset, there is a potential...". 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-2088-2013
Classification: Class II
Status: Terminated
Initiated: 2013-06-19
Posted: 2013-08-26
Terminated: 2014-08-27
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Dimension Vista 500 and Dimension Vista 1500 System Aliquot Well Double Dispense with software versions 3.5.1 and 3.6. 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 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 is conducting a field correction for Dimension Vista 500 and Dimension Vista 1500 systems using software versions 3.5.1 and 3.6. Under specific rare conditions which require a system reset, there is a potential for a sample to be dispensed into an aliquot well that has previously been used for a QC or calibrator product from a Vista vial. If two samples are dispensed into the same aliquot
Root cause tag: software
FDA root cause: Software Design Change
Action: The firm, Siemens, sent an "Urgent Medical Device Correction" letter dated June 2013 to its consignees/customers. The letter describes the product, problem and actions to be taken. The customers were instructed to take the following actions: 1) In the event that an instrument Reset is required for any reason, review the Current Activities Screen to determine if there are any pending QC or Calibration tests. 2) If there are no pending QC of Calibration tests, Rest the instrument or troubleshoot the instrument per the Operators Guide. 3) If there are pending QC or Calibration tests, restarting the software is necessary before resuming patient processing. Go to Operation -> Shutdown, confirm Yes, then on the blue console menu screen select start Vista. Consignees/customers were also asked to complete the Field Effectiveness Check form attached to the letter via fax to Siemens Healthcare Diagnostics at (302) 621-8467, and retain the letter with laboratory records, and forward the letter to those who may have received the product. If you have any questions, contact your Siemens Customer Care Center at (800-441-9250)-Technical Solutions or your local Siemens Technical Support representative.
Quantity in commerce: 1937
Distribution: Worldwide distribution: US (nationwide) including PR and countries of: Australia, Austria, Belgium, Canada, Czech Republic, Denmark, Finland, France, Germany, Italy, Japan, Malaysia, Netherlands, New Zealand, Norway, Portugal, Republic Korea, Saudia Arabia, Slovakia, Slovenia, South Africa, Spain, Switzerland, and United Kingdom.
Product codes and lots: Dimension Vista 500 Siemens material numbers: 10284473 (domestic), and 10488224 (international), Dimension Vista 1500 Siemens material numbers: 10444801 (domestic) and 10444802 (international).

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2088-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2088-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-04	2013-08-26

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)