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Siemens Medical Solutions USA, Inc. recalls Symbia E camera system. Emission Computed Tomography System used to detect or image the distribution of radionuclides i

Recalled July 23, 2014 · FDA recall Z-2043-2014 · Siemens Medical Solutions USA

Hazard
Siemens Medical Solutions USA, Inc. has received reports indicating the collimator cart rear casters may become loose. · FDA Class II
Units
531 systems
Sold at
Worldwide Distribution- US: Nationwide (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 ; WY) + District of Columbia + Puerto Rico; FOREIGN: Albania ; Algeria ; Angola ; Argentina ; Australia ; Austria ; Azerbaijan ; Bahrain ; Bangladesh ; Belarus ; Belgium ; Botswana ; Brazil ; Bulgaria ; Canada ; Chile ; China ; Colombia ; Costa Rica ; Croatia ; Cuba ; Czech Republic ; Dominican Rep. ; Ecuador ; Egypt ; El Salvador ; Finland ; France ; Georgia ; Germany ; Ghana ; Greece ; Hong Kong ; India ; Indonesia ; Iran ; Iraq ; Ireland ; Israel ; Italy ; Jamaica ; Japan ; Jordan ; Kazakhstan ; Kuwait ; Macedonia ; Malaysia ; Mexico ; Morocco ; Myanmar ; Netherlands ; New Zealand ; Niger ; Nigeria ; Norway ; Oman ; Pakistan ; Palestinian Territory ; Peru ; Philippines ; Poland ; Portugal ; Qatar ; Romania ; Russia ; Saudi Arabia ; Serbia ; Singapore ; Slovakia ; Slovenia ; South Africa ; South Korea ; Spain ; Sri Lanka ; Sweden ; Switzerland ; Syria ; Taiwan ; Thailand ; Trinidad and Tobago ; Tunisia ; Turkey ; Ukraine ; United Arab Emirates ; United Kingdom ; Uruguay ; Vietnam ; Yemen.

Description

Siemens Medical Solutions USA, Inc. has received reports indicating the collimator cart rear casters may become loose.

Product
Symbia E camera system. Emission Computed Tomography System used to detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588 keV. Nuclear medicine diagnostic device.
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 Symbia E camera system. Emission Computed Tomography System used to detect or image the distribution of radionuclides i | RecallWatchUSA