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.
4 linked reportsInjury 3Malfunction 1
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
1
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
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
2
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
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)
Failure-mode summaryAI-generated
4 linked report narratives available — no AI summary generated yet.
Recall history
Initiated
Recall #
Class
Status
Reason
Quantity
Link basis
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
2023-08-29
3004977335-2023-00102
Injury
Available
exact di
2023-07-05
3004977335-2023-00054
Malfunction
Available
model number
2020-05-11
3004977335-2020-26849
Injury
Available
model number
Showing the most recent 3 of 4 linked reports.
Regulatory clearances
510(k)K133590Substantially equivalent (SESE) · 2014-04-30clearance family
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.