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Siemens Medical Solutions USA, Inc. recalls e.cam camera system. Emission Computed Tomography System used to detect or image the distribution of radionuclides in t

Recalled July 23, 2014 · FDA recall Z-2042-2014 · 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
2,458 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
e.cam 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