Z-2561-2014Class II

Siemens EasyLink Informatics System V4.0/V5 Siemens, Material Number (SMN) 10444799, 10444800, 10487219 A...

Name: Z-2561-2014 Siemens EasyLink Informatics System V4.0/V5 Siemens, Material Number (SMN) 10444799, 10444800, 10487219 A...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2013-08-13
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2013-08-13 / Terminated / root cause: software

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Siemens EasyLink Informatics System V4.0/V5 Siemens, Material Number (SMN) 10444799, 10444800, 10487219 A clinical data management system that assists medical... on 2013-08-13. FDA classified it as Class II and gives the reason as "May not perform as intended under certain conditions, causing the release of results to the Laboratory Information System (LIS) that should have been held for manual review due to auto-verification rules or 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-2561-2014
Classification: Class II
Status: Terminated
Initiated: 2013-08-13
Posted: 2014-09-01
Terminated: 2014-12-02
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Siemens EasyLink Informatics System V4.0/V5 Siemens, Material Number (SMN) 10444799, 10444800, 10487219 A clinical data management system that assists medical laboratory professionals with preanalytic and post-analytic functions in conjunction with multiple instruments, the laboratory information system (LIS) and Siemens StreamLAB Automation Solutions.
Product code: JQP Calculator/Data Processing Module, For Clinical Use
Reason for recall: May not perform as intended under certain conditions, causing the release of results to the Laboratory Information System (LIS) that should have been held for manual review due to auto-verification rules or the delay/omission of result transmission to the LIS.
Root cause tag: software
FDA root cause: Software design
Action: Siemens issued an Urgent Medical Device Correction (UMDC) letter on August 13, 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to review this letter in its entirety and ensure that all operators understand the information presented. The issues described are specific to the features listed in the letter.. If the laboratory is not using a particular feature, then they are not affected by the issues described for that feature. For questions contact your Siemens Customer Care Center or your local Siemens technical support representative.
Quantity in commerce: 1347
Distribution: US Nationwide Distribution
Product codes and lots: EasyLink Informatics System V4.0/V5 Siemens Material Number (SMN) 10444799, 10444800, 10487219

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2561-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2561-2014	Class II	Terminated	Voluntary: Firm initiated	2014-09-10	2014-09-01

Product code JQP

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)