Terminated

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.

FDA Recall Z-2042-2014 · Posted 2014-07-11

Recalling FirmSiemens Medical Solutions USA, Inc.

Recall StatusTerminated

Product CodeKPS

Date Initiated2014-04-23

Date Terminated2016-12-23

Product Quantity2,458 systems

Reason for Recall

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

Firm Action

A Customer Safety Advisory Notice dated April 23, 2014 was sent to every direct account. The letter included instructions for direct accounts to discontinue use of the collimator cart and notify the local service representative if they notice or suspect tha one or more casters are loose (which would be indicated by shaking while the cart is in motion). Otherwise, a service representative will be contacting the direct account within the following 3 months to schedule a retention bracket installation. Direct accounts with questions can contact Siemens Medical Solutions USA, Inc. at 800-888-7436.

Root Cause

Device Design

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K131634SYMBIASiemens Medical Solutions USA, Inc. · 2013-08-16

Official Source

View FDA Recall →

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