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Recall Observatory FDA recall evidence

Device product

Aptio Automation Modules

Z-0590-2017

September 29, 2016

Class II

Product summary

Firm
Siemens Healthcare Diagnostics, Inc.
Event
Event 75417
Status
Terminated
Classification
Class II
Quantity
448 units
Official record key
device-enforcement:Z-0590-2017

Official wording

Reason: Possible overheating of power cord plugs used to connect to FlexLab and Aptio Automation systems.

Code information: "Refrigerated Storage Module (RSM): 10703049, 10715227, 10703036, 10713762, 10713767; "Centrifuge Module (CM): 10703032, 10713761, 10713764; "i2000SR Interface Module (i2000SR): 10989303, 10989304.

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Possible overheating of power cord plugs used to connect to FlexLab and Aptio Automation systems.