FDA-Device2016-11-23Class II

Aptio Automation Modules

Siemens Healthcare Diagnostics, Inc.
Hazard

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

Sold states
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
Affected count
448 units
Manufactured in
500 Gbc Dr Ms 514, PO BOX 6101, Newark, DE, United States
Products
Aptio Automation Modules

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0590-2017

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