Adverse-event reports (MAUDE)
Read this first: 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 shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.
2 linked reportsMalfunction 2
| 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 |
Failure-mode summaryAI-generated
2 linked report narratives available — no AI summary generated yet.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | 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 exposureDistribution: USA (nationally) Distribution. | 1301 | clearance family |
| 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 exposureDistribution: USA (nationally) Distribution. | 1301 | clearance family |
| 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 exposureDistribution: USA (nationally) Distribution. | 1301 | clearance family |
| 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 exposureDistribution: USA (nationally) Distribution. | 1301 | clearance family |
| 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".Distribution: US (nationwide) including Guam and the states of AL, AR, AZ, CA, CO, FL, GA, HI, IA, ID, IL, KY, MA, MD, ME, MI, MN, MO, NC, NJ, NM, NY, OH, PA, SC, TN, TX, VA, and WA. | 124 units | clearance family |
| 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.Distribution: US Nationwide Distribution in the states of IA, TX, FL, NE, NY, OH, NC, KS, IL, CA, OK including PR. | 345 | clearance family |
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2025-08-05 | 3004977335-2025-00094 | Malfunction | Available | exact di |
| 2022-01-13 | 3004977335-2022-10590 | Malfunction | Available | exact di |
Regulatory clearances
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2014-09-25 | NAI | No action indicated | Siemens AG/Siemens Healthcare GmbH | 0 |
| 2011-06-09 | VAI | Voluntary action indicated | Siemens Healthcare GmbH | 1 |
| 2010-09-14 | NAI | No action indicated | Siemens AG/Siemens Healthcare GmbH | 0 |
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