Z-1944-2014Class II

syngo Lab Data Manager, SMN 10800057, 10803189, and 10804573

Name: Z-1944-2014 syngo Lab Data Manager, SMN 10800057, 10803189, and 10804573
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2014-05-20
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2014-05-20 / Terminated / root cause: design

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of syngo Lab Data Manager, SMN 10800057, 10803189, and 10804573 on 2014-05-20. FDA classified it as Class II and gives the reason as "Certain configuration parameters may cause the reference ranges to not hold results as expected and release them to the Laboratory Information System (LIS) that should have been held for manual review". 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-1944-2014
Classification: Class II
Status: Terminated
Initiated: 2014-05-20
Posted: 2014-06-30
Terminated: 2015-08-10
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: syngo Lab Data Manager, SMN 10800057, 10803189, and 10804573.
Product code: JQP Calculator/Data Processing Module, For Clinical Use
Reason for recall: Certain configuration parameters may cause the reference ranges to not hold results as expected and release them to the Laboratory Information System (LIS) that should have been held for manual review.
Root cause tag: design
FDA root cause: Device Design
Action: An urgent medical device correction notice, dated May 20, 2014, was sent to end users to provide instructions to avoid potential risks associated with the software defect, until changes can be made by a Siemens technical representative.
Quantity in commerce: 336
Distribution: Worldwide Distribution. US Nationwide, Canada, Australia, Belgium, Czech Republic, Germany, Denmark, Finland, France, United Kingdom, Italy, Netherlands, Portugal, Slovakia, Singapore, Japan, and Spain.
Product codes and lots: syngo Lab Data Manager Application Software versions VA11B, VA12A, and VA12B

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1944-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1944-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-09	2014-06-30

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)