FDA-Device2015-01-21Class II
Symbia T and Symbia T2 computer tomography systems. These systems are used to perform SPECT, CT, and SPECT + CT scans and imaging studies.
Siemens Medical Solutions USA, Inc.
Hazard
There are confirmed reports of a component coming loose inside the CT enclosure and damaging the system. components.
Sold states
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, New Zealand, Norway, Philippines, Poland, Portugal, Russia, Singapore, Slovakia, Slovenia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, and Tunisia.
Affected count
295 systems
Manufactured in
2501 Barrington Rd, Hoffman Estates, IL, United States
Products
Symbia T and Symbia T2 computer tomography systems. These systems are used to perform SPECT, CT, and SPECT + CT scans and imaging studies.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0960-2015Don't want to check this manually?
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