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DIAGNOSTIC ULTRASOUND SYSTEM
Model SSH-880CV · CANON INC. · DI 04987670106514
ITX — Transducer, Ultrasonic, Diagnostic · Class II · 21 CFR 892.1570
IYN — System, Imaging, Pulsed Doppler, Ultrasonic · Class II · 21 CFR 892.1550
IYO — System, Imaging, Pulsed Echo, Ultrasonic · Class II · 21 CFR 892.1560
UDILibrary device dossier · generated 2026-09-15 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.
Recall history (4)
Initiated
Recall #
Class
Status
Reason
Link basis
2010-10-01
Z-2897-2011
Terminated
Toshiba America Medical Systems, Inc. is initiating a field correction on the Aplio Artida Ultrasound Diagnostic System because the panel operation for the Aplio Artida may become disabled (i.e., system may hang up) when processing to display patient information (heart rate, time, VCP counter, ect.).
k number procode
2010-09-28
Z-1498-2011
Terminated
Toshiba America Medical Systems is initiating a field correction on the SSH-880CV Aplio Artida Diagnostic Ultrasound System due to software issues.
k number procode
2010-04-20
Z-2179-2011
Terminated
There is a possibility of the system shutting down owing to the power supply unit causing the protection function to activate thus turning off the system prematurely.
k number procode
2010-01-06
Z-2203-2011
Terminated
Toshiba America Medical Systems (TAMS) has become aware that the FLEX M software has reversed left and right annotation and post FLEX M measurement error, which may result in incorrect values.
k number procode
Adverse-event reports — MAUDE (0)
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.
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
3.15
2019-02
0
5.46
2019-03
0
5.81
2019-04
0
3.3
2019-05
0
5.27
2019-06
0
6.28
2019-07
0
5.59
2019-08
0
7.45
2019-09
0
3.92
2019-10
0
3.57
2019-11
0
4.04
2019-12
0
4.84
2020-01
0
2.75
2020-02
0
5.41
2020-03
0
5.5
2020-04
0
5.17
2020-05
0
2.89
2020-06
0
3.16
2020-07
0
4.32
2020-08
0
2.93
2020-09
0
2.07
2020-10
0
3.79
2020-11
0
4.01
2020-12
0
5.87
2021-01
0
6.53
2021-02
0
4.61
2021-03
0
7.44
2021-04
0
4.17
2021-05
0
5.98
2021-06
0
6.44
2021-07
0
8.34
2021-08
0
7.22
2021-09
0
9.35
2021-10
0
5.7
2021-11
0
6.88
2021-12
0
9.64
2022-01
0
6.49
2022-02
0
8.37
2022-03
0
7.24
2022-04
0
8.11
2022-05
0
9.67
2022-06
0
7.56
2022-07
0
7.46
2022-08
0
5.42
2022-09
0
4.73
2022-10
0
4.62
2022-11
0
4.41
2022-12
0
5.16
2023-01
0
5.01
2023-02
0
4.61
2023-03
0
5.75
2023-04
0
3.78
2023-05
0
6.15
2023-06
0
4.06
2023-07
0
4.25
2023-08
0
5.94
2023-09
0
5.7
2023-10
0
6.69
2023-11
0
5.36
2023-12
0
5.47
2024-01
0
6.28
2024-02
0
4.31
2024-03
0
5.97
2024-04
0
5.86
2024-05
0
4.16
2024-06
0
5.85
2024-07
0
4.97
2024-08
0
5.4
2024-09
0
5.79
2024-10
0
6.4
2024-11
0
4.03
2024-12
0
11.27
2025-01
0
4.34
2025-02
0
4.03
2025-03
0
5.83
2025-04
0
3.25
2025-05
0
3.93
2025-06
0
4.11
2025-07
0
4.1
2025-08
0
5.45
2025-09
0
6.52
2025-10
0
9.71
2025-11
0
12.53
2025-12
0
18.81
2026-01
0
11.99
2026-02
0
6.63
2026-03
0
8.63
2026-04
0
11.88
2026-05
0
16.78
2026-06
0
15.26
This device (reports/month)Average device in ITX, IYN, IYO (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Predicate lineage
K090158 — cited as predicate by K110870, K121422, K121577
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — CANON INC.
NAI 2014-09-19 Canon Components, Inc. (Factory Site) · 0 citations