Z-0591-2017Class II

FlexLab Automation Modules

Name: Z-0591-2017 FlexLab Automation Modules
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2016-09-29
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2016-09-29 / Terminated

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of FlexLab Automation Modules on 2016-09-29. FDA classified it as Class II. As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0591-2017
Classification: Class II
Status: Terminated
Initiated: 2016-09-29
Posted: 2016-11-16
Terminated: 2018-09-19
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: FlexLab Automation Modules
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
FDA root cause: Under Investigation by firm
Action: Siemens mailed to customers an Urgent Field Safety Notification letter warning them of the problem and to inform them that Siemens Customer Service Engineers shall be visiting customer sites to replace the power cords.
Quantity in commerce: 448 units
Distribution: 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
Product codes and lots: Refrigerated Storage Module (RSM): 11171750. Centrifuge (CM): 11171747. i2000SR (i2000SR): 11171801.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0591-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0590-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-23	2016-11-16
Z-0591-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-23	2016-11-16

Product code JJE

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)