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ExacTrac Vero
Model 3.5 · Brainlab SE · DI 04056481132446
IYE — Accelerator, Linear, Medical · Class II · 21 CFR 892.5050
UDILibrary device dossier · generated 2026-09-13 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.
Recall history (2)
Initiated
Recall #
Class
Status
Reason
Link basis
2017-11-03
Z-0172-2018
Class II
Terminated
Brainlab has internally detected that under specific conditions ExacTrac Vero may not correctly account for this ring angle correction during the calculation of the corresponding couch shift. This may result in the treatment couch not moving to the exact planned position resulting in a deviation between the planned and the treatment target position. This deviation may not be clearly visible to the user if no verification image of the patient position is acquired after this couch shift has been performed.
code info di
2016-05-04
Z-1929-2016
Class II
Terminated
Potentially incorrect positioning when using Implanted Marker Detection with Brainlab ExacTrac Vero 3.5
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)
2019-02
0
1
2019-03
0
2.67
2019-04
0
2.33
2019-05
0
1.25
2019-07
0
1
2019-08
0
1.2
2019-09
0
4
2019-10
0
3
2019-11
0
1.33
2019-12
0
1.33
2020-01
0
3.6
2020-02
0
1.33
2020-03
0
1.83
2020-04
0
2.67
2020-05
0
4.2
2020-06
0
2.6
2020-07
0
1
2020-08
0
3.4
2020-10
0
4.75
2020-11
0
2.4
2020-12
0
3
2021-01
0
1.33
2021-02
0
1.67
2021-03
0
1.8
2021-04
0
1.8
2021-05
0
1.33
2021-06
0
2
2021-07
0
3.4
2021-08
0
2
2021-09
0
2
2021-10
0
1.17
2021-11
0
2.5
2021-12
0
4.25
2022-01
0
1.6
2022-02
0
1.4
2022-03
0
3.4
2022-04
0
1.33
2022-06
0
2.77
2022-07
0
3
2022-08
0
2.17
2022-09
0
2.17
2022-10
0
1.33
2022-11
0
2.82
2022-12
0
1.17
2023-01
0
4.57
2023-02
0
2.14
2023-03
0
3.57
2023-04
0
10.1
2023-05
0
6.29
2023-06
0
4.4
2023-07
0
3.22
2023-08
0
1.75
2023-09
0
2
2023-10
0
1.33
2023-11
0
2.33
2023-12
0
1.8
2024-01
0
1.17
2024-02
0
1
2024-03
0
1.33
2024-04
0
1.75
2024-05
0
2
2024-06
0
1
2024-07
0
1.6
2024-08
0
1
2024-09
0
1.25
2024-10
0
1.67
2024-11
0
3
2024-12
0
1
2025-01
0
1.6
2025-02
0
1.33
2025-03
0
1.5
2025-04
0
2
2025-05
0
2.67
2025-06
0
5.67
2025-07
0
1.5
2025-08
0
1.25
2025-09
0
1.67
2025-10
0
1
2025-11
0
1
2025-12
0
1
2026-01
0
1.5
2026-02
0
1
2026-03
0
1
2026-04
0
1
2026-05
0
1
2026-06
0
1
This device (reports/month)Average device in IYE (reports/device/month)
Regulatory clearances
K122451 SESE 2012-09-28 (k number procode)
Predicate lineage
K122451 — cites (transitively): K072046 (d1), K120233 (d1) — cited as predicate by K131965, K181789
Lineage extracted from public 510(k) summary text (heuristic).