Z-1991-2009

EasyLink Informatics System included with the Dimension Vista System. The Dimension Vista Integrated System...

Name: Z-1991-2009 EasyLink Informatics System included with the Dimension Vista System. The Dimension Vista Integrated System...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2009-07-14
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2009-07-14 / Terminated / root cause: software

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of EasyLink Informatics System included with the Dimension Vista System. The Dimension Vista Integrated System is an in vitro diagnostic device intended to... on 2009-07-14. The reason FDA records is "incorrect results may be transmitted to LIS". 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-1991-2009
Status: Terminated
Initiated: 2009-07-14
Posted: 2009-09-29
Terminated: 2010-01-05
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: EasyLink Informatics System included with the Dimension Vista System. The Dimension Vista Integrated 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.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: incorrect results may be transmitted to LIS
Root cause tag: software
FDA root cause: Software design
Action: Siemens issued an "Urgent Device Correction" letter dated July 2009. The letter informed the user of the affected product including instructions for avoiding the problem. For further information, contact Siemens Healthcare Diagnostics Technical Solution Center at 1-800-441-9250.
Quantity in commerce: 359 units
Distribution: Worldwide Distribution -- United States, Australia, Austria, Belgium, Canada, France, Germany, Italy, Japan, Malaysia, Netherlands, Portugal, Slovenia, Spain and Switzerland.
Product codes and lots: Part Number: 1000046623.

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)