Z-1391-2012

EasyLink(TM) Informatics Systems Software Version 5.0 and Software Version 5.0 Service Packs 1 through 4 used...

Name: Z-1391-2012 EasyLink(TM) Informatics Systems Software Version 5.0 and Software Version 5.0 Service Packs 1 through 4 used...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2011-12-02
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2011-12-02 / Terminated / root cause: design

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of EasyLink(TM) Informatics Systems Software Version 5.0 and Software Version 5.0 Service Packs 1 through 4 used with the Dimension Vista(R) System. The... on 2011-12-02. The reason FDA records is "QC results may be unexpectedly associated with a Pending Control. When this situation occurs, Pending QC Controls maybe be created or reused". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1391-2012
Status: Terminated
Initiated: 2011-12-02
Posted: 2012-04-10
Terminated: 2014-03-21
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: EasyLink(TM) Informatics Systems Software Version 5.0 and Software Version 5.0 Service Packs 1 through 4 used with the Dimension Vista(R) System. The EasyLink(TM) Informatics System is classified as a data calculator and processing module for use with In-vitro diagnostics devices. The EasyLink(TM) is included with the Dimension Vista(R) System, and may be used with other Siemens analyzers, as a communications and connectivity workstation for integration with laboratory information system (LIS) networks. Product Quantity Distributed (Int) 787
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: QC results may be unexpectedly associated with a Pending Control. When this situation occurs, Pending QC Controls maybe be created or reused.
Root cause tag: design
FDA root cause: Device Design
Action: Siemens Healthcare Diagnostic Inc, sent a Urgent Field Safety Notice dated December 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were asked to follow these instructions. The first option is Extending the "Minimum Inactive Days" to 999 days. The second option is to proactively monitor the system for unexpected Pending QC Controls. Long Term Action Plan: A corrective and preventive action (CAPA) investigation has been issued. Currently firm is actively investigating. Further questions please call (302) 631-0516.
Quantity in commerce: 787
Distribution: Worldwide Distribution -- USA (nationwide) and the countries of CANADA, FRANCE, GERMANY, SPAIN, PORTUGAL, ITALY, JAPAN, NORWAY, AUSTRALIA, AUSTRIA, NEW ZEALAND, BELGIUM, SWITZERLAND, NETHERLANDS, MALAYASIA, SLOVENIA, SOUTH KOREA, DENMARK, SAUDI ARABIA, SLOVAKIA, PUERTO RICO, INDONESIA and TAIWAN.
Product codes and lots: Catalog number 1000034805

Product code JJE

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)