Siemens Healthcare Diagnostics, Inc.: Medical Device Recall in 2019 - (Recall #: Z-1195-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: August 26, 2015

Date Posted: April 24, 2019

Recall Number: Z-1195-2019

Event ID: 82345

Reason for Recall:

Software Issues.

Status: Terminated

Product Quantity: 449 systems

Code Information:

Catalog Numbers: 10638933, 10624077, 10804573 510K Exempt

Distribution Pattern:

Worldwide distribution - US Nationwide and countries of Japan, Germany, Belgium, France, Italy, Slovakia, Bahamas, United Kingdom and Mexico.

Voluntary or Mandated:

Voluntary: Firm initiated