FDA Device recall Z-1297-2015

E.CAM emission computed tomography system used to detect or image the distribution of radionuclides in the body or organ, using the followi…

FDA Device
Class II
terminated
Published 2015-03-25

On 2015-03-25 the FDA classified a Class II recall of E.CAM emission computed tomography system used to detect or image the distribution of radionuclides in the body or organ, using the followi… by Siemens Medical Solutions Usa, citing radial motor drives replaced during a customer service action were incorrectly assembled backwards.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-1297-2015
Classification	Class II
Status	terminated
Initiated	2012-04-11
Published	2015-03-25
Last updated	2026-09-13 11:53 UTC
Company	Siemens Medical Solutions Usa
Distribution	US

Product

E.CAM 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.

Reason

Radial motor drives replaced during a customer service action were incorrectly assembled backwards.

Identifiers

code_info	1) E.CAM gantry single head; Material Number: 4380213 ; Serial Numbers: 1 , 2 , 1002 , 1003 , 1004 , 1005 , 1006… 1) E.CAM gantry single head; Material Number: 4380213 ; Serial Numbers: 1 , 2 , 1002 , 1003 , 1004 , 1005 , 1006 , 1007 , 1008 , 1009 , 1010 , 1011 , 1012 , 1013 , 1014 , 1015 , 1016 , 1017 , 1018 , 1019 , 1020 , 1021 , 1022 , 1028 , 1029 , 1030 , 1031 , 1032 , 1033 , 1034 , 1035 , 1036 , 1037 , 1038 , 1039 , 1040 , 1041 , 1042 , 1043 , 1044 , 1045 , 1046 , 1047 , 1048 , 1049 , 1051 , 1052 , 1053 , 1054 , 1055 , 1056 , 1057 , 1058 , 1065 , 2001 , 2002 , 2003 , 2004 , 2005 , 2006 , 2007 , 2008 , 2009 , 2010 , 2011 , 2012 , 2013 , 2014 , 2015 , 2016 , 2017 , 2018 , 2019 , 2020 , 2021 , 2022 , 2023 , 2024 , 2025 , 2026 , 2027 , 2028 , 3001 , 3002 , 3003 , 3004 , 3005 , 3006 , 3007 , 3008 , 3009 , 3010 , 3011 , 3012 , 3013 , 3014 , 3015 , 3016 , 3017 , 3018 , 3019 , 3020 , 3021 , 3022 , 3023 , 3024 , 3025 , 3026 , 3027 , 3028 , 10351 , 10352 , 1046A , 3024// ; 2) E.CAM gant

code_info

1) E.CAM gantry single head; Material Number: 4380213 ; Serial Numbers: 1 , 2 , 1002 , 1003 , 1004 , 1005 , 1006…

1) E.CAM gantry single head; Material Number: 4380213 ; Serial Numbers: 1 , 2 , 1002 , 1003 , 1004 , 1005 , 1006 , 1007 , 1008 , 1009 , 1010 , 1011 , 1012 , 1013 , 1014 , 1015 , 1016 , 1017 , 1018 , 1019 , 1020 , 1021 , 1022 , 1028 , 1029 , 1030 , 1031 , 1032 , 1033 , 1034 , 1035 , 1036 , 1037 , 1038 , 1039 , 1040 , 1041 , 1042 , 1043 , 1044 , 1045 , 1046 , 1047 , 1048 , 1049 , 1051 , 1052 , 1053 , 1054 , 1055 , 1056 , 1057 , 1058 , 1065 , 2001 , 2002 , 2003 , 2004 , 2005 , 2006 , 2007 , 2008 , 2009 , 2010 , 2011 , 2012 , 2013 , 2014 , 2015 , 2016 , 2017 , 2018 , 2019 , 2020 , 2021 , 2022 , 2023 , 2024 , 2025 , 2026 , 2027 , 2028 , 3001 , 3002 , 3003 , 3004 , 3005 , 3006 , 3007 , 3008 , 3009 , 3010 , 3011 , 3012 , 3013 , 3014 , 3015 , 3016 , 3017 , 3018 , 3019 , 3020 , 3021 , 3022 , 3023 , 3024 , 3025 , 3026 , 3027 , 3028 , 10351 , 10352 , 1046A , 3024// ; 2) E.CAM gant

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1297-2015%22

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