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Siemens Medical Solutions USA, Inc. recalls e.cam line of gamma camera systems Used to detect or image the distribution of radionuclides in the body or organ.

Recalled October 29, 2014 · FDA recall Z-0116-2015 · Siemens Medical Solutions USA

Hazard
Reports of loose bolts in the detector support structure of Symbia and e.cam systems. · FDA Class II
Units
4,862 devices
Sold at
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.

Description

Reports of loose bolts in the detector support structure of Symbia and e.cam systems.

Product
e.cam line of gamma camera systems Used to detect or image the distribution of radionuclides in the body or organ.
Manufacturer(s)
Siemens Medical Solutions USA, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov

Siemens Medical Solutions USA, Inc. recalls e.cam line of gamma camera systems Used to detect or image the distribution of radionuclides in the body or organ. | RecallWatchUSA