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SOMATOM Emotion 16-slice configuration
Model 10165977 · Siemens Shanghai Medical Equipment Ltd. · DI 04056869010304
JAK — System, X-Ray, Tomography, Computed · Class II · 21 CFR 892.1750
UDILibrary device dossier · generated 2026-09-12 · 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 (5)
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.
Injury: 5
| 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 | 2 | 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 | 0 | 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 | 1 | 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 | 0 | 1.5 |
| 2025-09 | 2 | 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 |
Regulatory clearances
- K183548 SESE 2019-04-15 (k number procode)
- K140232 SESE 2014-08-14 (k number procode)
Predicate lineage
K050297 — cited as predicate by K113287, K133590, K140912
K140232 — cites (transitively): K013522 (d1), K040577 (d1), K040655 (d1), K133424 (d1) — cited as predicate by K141971
K183548 — cited as predicate by K193178, K200474, K241898
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — Siemens Shanghai Medical Equipment Ltd.
- VAI 2019-01-17 Siemens Shanghai Medical Equipment Ltd. · 0 citations
- VAI 2015-07-23 Siemens Shanghai Medical Equipment Ltd. · 0 citations
- NAI 2011-05-12 Siemens Shanghai Medical Equipment Ltd. · 0 citations