PlainRecalls
FDA Devices Moderate Class II Terminated

e.cam line of gamma camera systems Used to detect or image the distribution of radionuclides in the body or organ.

Reported: October 29, 2014 Initiated: October 28, 2013 #Z-0116-2015

Product Description

e.cam line of gamma camera systems Used to detect or image the distribution of radionuclides in the body or organ.

Reason for Recall

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

Details

Units Affected
4,862 devices
Distribution
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.
Location
Hoffman Estates, IL

Frequently Asked Questions

What product was recalled?
e.cam line of gamma camera systems Used to detect or image the distribution of radionuclides in the body or organ.. Recalled by Siemens Medical Solutions USA, Inc.. Units affected: 4,862 devices.
Why was this product recalled?
Reports of loose bolts in the detector support structure of Symbia and e.cam systems.
Which agency issued this recall?
This recall was issued by the FDA Devices on October 29, 2014. Severity: Moderate. Recall number: Z-0116-2015.