Z-0433-2014Class II

syngo(R) Lab Data Manager - Version VA11B and VA12A Systems Securely consolidates data from multiple lab...

Name: Z-0433-2014 syngo(R) Lab Data Manager - Version VA11B and VA12A Systems Securely consolidates data from multiple lab...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2013-05-10
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2013-05-10 / Terminated / root cause: software

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of syngo(R) Lab Data Manager - Version VA11B and VA12A Systems Securely consolidates data from multiple lab instruments, the LIS and Siemens StreamLAB(R)... on 2013-05-10. FDA classified it as Class II and gives the reason as "Under certain conditions the system may not perform as intended, causing the release of results to the Laboratory Information System 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-0433-2014
Classification: Class II
Status: Terminated
Initiated: 2013-05-10
Posted: 2013-12-03
Terminated: 2014-08-26
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: syngo(R) Lab Data Manager - Version VA11B and VA12A Systems Securely consolidates data from multiple lab instruments, the LIS and Siemens StreamLAB(R) Automation Solutions. It provides autoverification, integrated QC capabilities, browser-based connectivity supporting up to 25 concurrent users, remote services to help keep systems running optimally and also has audit trail capabilities.
Product code: NSX
Reason for recall: Under certain conditions the system may not perform as intended, causing the release of results to the Laboratory Information System 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 sent an Urgent Medical Device Correction letter in May 2013 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review the letter in its entirety and ensure that all operators understand the information presented. Specific actions needed to be implemented by the customer were outlined in the letter. Customers were instructed to retain the letter with their laboratory records, and forward the letter to those who may have received the affected product. Customers with questions were instructed to contact their Siemens Technical Solutions Center or their local Siemens technical support representative. For questions regarding this recall call 800-441-9250.
Quantity in commerce: 262
Distribution: Worldwide Distribution: USA (nationwide) and internationally to Canada.
Product codes and lots: Siemens Material Number 10800057 (Version VA11B) and 10803188 (Version VA12A)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0433-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0433-2014	Class II	Terminated	Voluntary: Firm initiated	2013-12-11	2013-12-03

Product code NSX

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)