Siemens Healthcare Diagnostics, Inc.: Medical Device Recall in 2016 - (Recall #: Z-0591-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

FlexLab Automation Modules

Product Classification:

Class II

Date Initiated: September 29, 2016

Date Posted: November 23, 2016

Recall Number: Z-0591-2017

Event ID: 75417

Reason for Recall:

Status: Terminated

Product Quantity: 448 units

Code Information:

Refrigerated Storage Module (RSM): 11171750. Centrifuge (CM): 11171747. i2000SR (i2000SR): 11171801.

Distribution Pattern:

Distributed Nationwide and to the following countries: Australia, Azerbaijan, Bahrain, Bangladesh, Belgium, Brazil, Canada, Czech Republic, Denmark, Egypt, Germany, Greece, Indonesia, Italy, Kingdom Saudi Arabia, Lebanon, Malaysia, P.R. China, Philippines, Portugal, Qatar, Republic Korea, Saudi Arabia, Spain, Sweden, Switzerland, Taiwan, Turkey, U.A.E., United Kingdom, Vietnam

Voluntary or Mandated:

Voluntary: Firm initiated