Z-1195-2019Class II

syngo Lab Data Manager System -

Name: Z-1195-2019 syngo Lab Data Manager System -
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2015-08-26
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2015-08-26 / Terminated / root cause: design

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of syngo Lab Data Manager System - Product Usage: syngo Lab Data Manager is a clinical system that assists medical laboratory professions with pre-analytic and... on 2015-08-26. FDA classified it as Class II and gives the reason as "Software Issues". 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-1195-2019
Classification: Class II
Status: Terminated
Initiated: 2015-08-26
Posted: 2019-04-18
Terminated: 2020-03-24
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: syngo Lab Data Manager System - Product Usage: syngo Lab Data Manager is a clinical system that assists medical laboratory professions with pre-analytic and post-analytic functions. It works in conjunction with multiple instruments, the laboratory information system (LIS) and the Siemens Healthcare Diagnostics Data Center. It supports the Siemens analyzers through delivery of applications and connectivity features.
Product code: JQP Calculator/Data Processing Module, For Clinical Use
Reason for recall: Software Issues.
Root cause tag: design
FDA root cause: Device Design
Action: Siemens mailed an Urgent Field Safety Notice and an Urgent Field Correction Letter to affected customers on 08/26/2015 to inform them of the issue. The reason for the correction, risk to health and actions to be taken were explained in the notice.
Quantity in commerce: 449 systems
Distribution: Worldwide distribution - US Nationwide and countries of Japan, Germany, Belgium, France, Italy, Slovakia, Bahamas, United Kingdom and Mexico.
Product codes and lots: Catalog Numbers: 10638933, 10624077, 10804573 510K Exempt

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1195-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1195-2019	Class II	Terminated	Voluntary: Firm initiated	2019-04-24	2019-04-18

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)