FDA-Device2014-10-29Class II

Symbia E is a multi-purpose SPECT system ideal for hospitals and outpatient centers. It is used to detect or image the distribution of radionuclides in the body or organ.

Siemens Medical Solutions USA, Inc.
Hazard

Reports of loose bolts in the detector support structure of Symbia and E.CAM systems.

Sold states
Worldwide Distribution -- USA, including the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY; and, the District of Columbia, Guam, and Puerto Rico; and, the countries of Albania, Algeria, Angola, Argentina, Austria, Australia, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Bulgaria, Cameroon, Canada, Chile, China, Columbia, Congo, Costa Rica, Cuba, Croatia, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Georgia, Germany, Greece, Honduras, Hong Kong, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kuwait, Latvia, Lebanon, Luxembourg, Macedonia, Madagascar, Malaysia, Mexico, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Niger, Nigeria, Norway, Oman, Pakistan, Palestine, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Sri Lanka, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tobago, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Vietnam, and Yemen.
Affected count
562 devices
Manufactured in
2501 Barrington Rd, Hoffman Estates, IL, United States
Products
Symbia E is a multi-purpose SPECT system ideal for hospitals and outpatient centers. It is used to detect or image the distribution of radionuclides in the body or organ.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0115-2015

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