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Somatom Perspective (DE)
Model 10046733 · Siemens Healthcare GmbH · DI 04056869013039
JAK — System, X-Ray, Tomography, Computed · Class II · 21 CFR 892.1750
UDILibrary device dossier · generated 2026-09-11 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.
Recall history (1)
Initiated
Recall #
Class
Status
Reason
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.
k number procode
Adverse-event reports — MAUDE (4)
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: 3 · Malfunction: 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)
Regulatory clearances
K133590 SESE 2014-04-30 (k number procode)
Predicate lineage
K133590 — cites (transitively): K050297 (d1) — cited as predicate by K142955, K151765, K152880
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — Siemens Healthcare GmbH
NAI 2014-09-25 Siemens AG/Siemens Healthcare GmbH · 0 citations
VAI 2011-06-09 Siemens Healthcare GmbH · 1 citations
NAI 2010-09-14 Siemens AG/Siemens Healthcare GmbH · 0 citations