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SOMATOM Emotion 16 Slice (DE)
Model 10046789 · Siemens Healthcare GmbH · DI 04056869013114
JAK — System, X-Ray, Tomography, Computed · Class II · 21 CFR 892.1750
UDILibrary device dossier · generated 2026-09-07 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.
Recall history (6)
Initiated
Recall #
Class
Status
Reason
Link basis
2018-02-15
Z-1452-2018
Class II
Terminated
to inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a. (posterior-anterior) or a.p. (anterior-posterior) topograms. Depending on the geometrical shape of the skull bone, it may happen in rare cases that the calculated dose distribution is not appropriate and could lead to unnecessary radiation exposure
k number procode
2018-02-15
Z-1453-2018
Class II
Terminated
to inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a. (posterior-anterior) or a.p. (anterior-posterior) topograms. Depending on the geometrical shape of the skull bone, it may happen in rare cases that the calculated dose distribution is not appropriate and could lead to unnecessary radiation exposure
k number procode
2018-02-15
Z-1454-2018
Class II
Terminated
to inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a. (posterior-anterior) or a.p. (anterior-posterior) topograms. Depending on the geometrical shape of the skull bone, it may happen in rare cases that the calculated dose distribution is not appropriate and could lead to unnecessary radiation exposure
k number procode
2018-02-15
Z-1459-2018
Class II
Terminated
To inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a. (posterior-anterior) or a.p. (anterior-posterior) topograms. Depending on the geometrical shape of the skull bone, it may happen in rare cases that the calculated dose distribution is not appropriate and could lead to unnecessary radiation exposure
k number procode
2016-02-15
Z-1301-2016
Class II
Terminated
Siemens is initiating this recall due to a potential malfunction and hence potential hazard to patients and personnel when using the SOMATOM Emotion or SOMATOM Sensation systems in conjunction with the use of the cardio licenses "Cardio Pro" and "Cardio Retro".
k number procode
2014-03-21
Z-1721-2014
Class II
Terminated
The rubber damper may degrade and break, causing loosening of the motor mounting plates, which could lead to a series of events that could place the operator and patient at risk of injury.
k number procode
Adverse-event reports — MAUDE (2)
Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.
Malfunction: 2
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2019-01
0
5.1
2019-02
0
3.3
2019-03
0
3.25
2019-04
0
5.91
2019-05
0
3.25
2019-06
0
2.8
2019-07
0
2.58
2019-08
0
2.43
2019-09
0
2.14
2019-10
0
2.25
2019-11
0
1.86
2019-12
0
5.33
2020-01
0
2
2020-02
0
2.75
2020-03
0
2.2
2020-04
0
3.67
2020-05
0
2
2020-06
0
2.44
2020-07
0
2.25
2020-08
0
1.74
2020-09
0
2
2020-10
0
2.05
2020-11
0
2.24
2020-12
0
2.4
2021-01
0
1.47
2021-02
0
1.81
2021-03
0
2.43
2021-04
0
2.74
2021-05
0
3.77
2021-06
0
4.55
2021-07
0
3.07
2021-08
0
2.53
2021-09
0
2.3
2021-10
0
1.67
2021-11
0
2.62
2021-12
0
2.75
2022-01
1
1.89
2022-02
0
2.47
2022-03
0
2.43
2022-04
0
2.42
2022-05
0
1.89
2022-06
0
1.88
2022-07
0
3.53
2022-08
0
1.86
2022-09
0
2.84
2022-10
0
2.09
2022-11
0
2.07
2022-12
0
1.65
2023-01
0
2.31
2023-02
0
1.9
2023-03
0
2.63
2023-04
0
2.17
2023-05
0
2.57
2023-06
0
6.84
2023-07
0
2.1
2023-08
0
3.42
2023-09
0
2.95
2023-10
0
5.89
2023-11
0
2.58
2023-12
0
2.9
2024-01
0
1.9
2024-02
0
1.88
2024-03
0
1.89
2024-04
0
1.65
2024-05
0
2.06
2024-06
0
3.08
2024-07
0
1.88
2024-08
0
1.3
2024-09
0
1.17
2024-10
0
1.95
2024-11
0
1.45
2024-12
0
1.69
2025-01
0
1.59
2025-02
0
1.61
2025-03
0
1.39
2025-04
0
1.86
2025-05
0
2.5
2025-06
0
1.54
2025-07
0
1.5
2025-08
1
1.5
2025-09
0
1.67
2025-10
0
1.1
2025-11
0
1.29
2025-12
0
2.41
2026-01
0
2.22
2026-02
0
1.68
2026-03
0
1.45
2026-04
0
2
2026-05
0
2.19
2026-06
0
1.55
This device (reports/month)Average device in JAK (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Predicate lineage
K050297 — cited as predicate by K113287, K133590, K140912
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — Siemens Healthcare GmbH
NAI 2014-09-25 Siemens AG/Siemens Healthcare GmbH · 0 citations
VAI 2011-06-09 Siemens Healthcare GmbH · 1 citations
NAI 2010-09-14 Siemens AG/Siemens Healthcare GmbH · 0 citations