PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: January 21, 2015 Initiated: March 5, 2014 #Z-0960-2015

Product Description

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

Reason for Recall

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

Details

Units Affected
295 systems
Distribution
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.
Location
Hoffman Estates, IL

Frequently Asked Questions

What product 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.. Recalled by Siemens Medical Solutions USA, Inc.. Units affected: 295 systems.
Why was this product recalled?
There are confirmed reports of a component coming loose inside the CT enclosure and damaging the system. components.
Which agency issued this recall?
This recall was issued by the FDA Devices on January 21, 2015. Severity: Moderate. Recall number: Z-0960-2015.