Medical device recalls Moderate risk

Siemens Medical Solutions USA, Inc. recalls Symbia T and Symbia T2 computer tomography systems. These systems are used to perform SPECT, CT, and SPECT + CT scans a…

Recall date
March 5, 2014
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0960-2015
FDA classification
Class II
Brand / firm
Siemens Medical Solutions USA, Inc.
Sold / distributed
Worldwide Distribution: US Nationwide including Puerto Rico; Austria, Australia, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Czech Republic, Ecuador, Egypt, Finland, France, Germany, Great Britain, Hungary, Ireland, India, Iran, Italy, Japan, Mexico, Netherlands,…

Why it was recalled

There are confirmed reports of a component coming loose inside the CT enclosure and damaging the system. components.

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

What was recalled

Symbia T and Symbia T2 computer tomography systems. These systems are used to perform SPECT, CT, and SPECT + CT scans and imaging studies.

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