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.
15 linked reportsInjury 12Malfunction 3
| 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 | 1 | 2.25 |
| 2019-11 | 0 | 1.86 |
| 2019-12 | 0 | 5.33 |
| 2020-01 | 2 | 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 | 3 | 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 | 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 | 6 | 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 | 3 | 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
15 linked report narratives available — no AI summary generated yet.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2018-02-15 | Z-1448-2018 | 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 |
| 2018-02-01 | Z-2474-2018 | Class II | Terminated | A potential risk of unnecessary radiation exposure due to a software issueDistribution: Nationwide | N/A | clearance family |
| 2018-02-01 | Z-2475-2018 | Class II | Terminated | A potential risk of unnecessary radiation exposure due to a software issueDistribution: Nationwide | N/A | clearance family |
| 2016-11-22 | Z-0921-2017 | Class II | Terminated | Siemens is providing a new installation of the Residual Current Monitor (RCM) in the Line Connection Box (LCB) to resolve a potential defect that could lead to a power cutout during use of the SOMATOM Scope, Scope Power and Perspective systems.Distribution: Distributed to: IL IL GA SC SD OK NY MI IN MD AR | 13 systems | clearance family |
| 2015-04-20 | Z-1646-2015 | Class II | Terminated | Software bugs in VC20B SP0a or SP1 software versions may cause issues that could make it necessary to rescan patients. Syngo Main UI may crash if the Patient Browser is scrolled with arrow keys of the keyboard. Tomo images may freeze on the screen when zoomed in or out under the mode of CAREVision. Sporadic displaying error in WorkStream4D application. DB may lock under heavy and multitasks.Distribution: Nationwide Distribution including Puerto Rico. | 75 | clearance family |
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2025-09-17 | 3003202425-2025-00005 | Injury | Available | exact di |
| 2024-10-14 | 3003202425-2024-00003 | Injury | Available | exact di |
| 2024-10-14 | 3003202425-2024-00004 | Injury | Available | exact di |
| 2021-07-28 | 3003202425-2021-88036 | Malfunction | Available | exact di |
| 2020-01-22 | 3003202425-2020-14807 | Injury | Available | model number |
| 2019-10-28 | 3003202425-2019-01895 | Injury | Available | procode brand trgm |
Showing the most recent 6 of 15 linked reports.
Regulatory clearances
- 510(k)K183548Substantially equivalent (SESE) · 2019-04-15clearance family
- 510(k)K151765Substantially equivalent (SESE) · 2016-03-25clearance family
- 510(k)K133590Substantially equivalent (SESE) · 2014-04-30clearance family
- 510(k)K113287Substantially equivalent (SESE) · 2012-05-23clearance family
Predicate lineage
Cited as predicate by: K170904
Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2019-01-17 | VAI | Voluntary action indicated | Siemens Shanghai Medical Equipment Ltd. | 0 |
| 2015-07-23 | VAI | Voluntary action indicated | Siemens Shanghai Medical Equipment Ltd. | 0 |
| 2011-05-12 | NAI | No action indicated | Siemens Shanghai Medical Equipment Ltd. | 0 |
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