Terminated

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

FDA Recall Z-0116-2015 · Posted 2014-10-22

Recalling FirmSiemens Medical Solutions USA, Inc.

Recall StatusTerminated

Product CodeKPS

Date Initiated2013-10-28

Date Terminated2016-12-23

Product Quantity4,862 devices

Reason for Recall

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

Firm Action

Undated "Customer Safety Advisory Notice" letters were sent to all direct accounts (customers). The letters stated the problem, and included instructions for customers. Customers: 1) can continue to use the devices while waiting for an inspection to be scheduled and performed; and, 2) their local service engineer will inspect the detector pivot connections and make any necessary repairs on site. Customers with any questions can contact their local service representative or Siemens Molecular Imaging at 800-888-7436.

Root Cause

Process control

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K952109IP500 NUCLEAR GAMMA CAMERA SYSTEMSiemens Medical Solutions USA, Inc. · 1995-08-23

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.