Medical device recalls Moderate risk

Aptio Automation Modules recalled over fire hazard

Recall date
September 29, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Siemens Healthcare Diagnostics, Inc. recalls Aptio Automation Modules
Recall number
Z-0590-2017
FDA classification
Class II
Brand / firm
Siemens Healthcare Diagnostics, Inc.
Sold / distributed
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 Ara…

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Aptio Automation Modules

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