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RT QA Element
Model 1.0 · Brainlab SE · DI 04056481007119
MUJ — System, Planning, Radiation Therapy Treatment · Class II · 21 CFR 892.5050
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 (3)
Initiated
Recall #
Class
Status
Reason
Link basis
2019-03-11
Z-1205-2019
Class II
Terminated
There is a potential for an incorrect dose distribution calculation by Brainlab RT Elements software (for affected versions) under specific circumstances when using the Pencil Beam algorithm on the GPU (graphics card), as is the default system setting.
code info di
2015-11-05
Z-0647-2016
Class II
Terminated
Large objects with fine resolution are potentially displayed cropped when imported into Brainlab Brain Metastases 1.0.0.
k number procode
2015-11-05
Z-0648-2016
Class II
Terminated
Large objects with fine resolution are potentially displayed cropped when imported into Adaptive Hybrid Surgery Analysis version 1.0.0
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)
2019-04
0
1
2019-05
0
1.14
2019-06
0
2.29
2019-07
0
1.14
2019-08
0
1.57
2019-09
0
1
2019-10
0
1
2019-11
0
1.14
2019-12
0
1
2020-02
0
1.14
2020-03
0
4.57
2020-04
0
2.29
2020-05
0
1.14
2020-07
0
2.13
2020-08
0
1
2020-09
0
1.14
2020-11
0
2
2021-07
0
2.29
2021-08
0
2.29
2021-10
0
1.71
2021-12
0
1.5
2022-01
0
1
2022-02
0
1
2022-03
0
1
2022-06
0
2
2022-08
0
1
2022-09
0
1
2022-11
0
1.33
2022-12
0
1.5
2023-01
0
1.14
2023-03
0
2.5
2023-04
0
1.67
2023-09
0
1
2023-10
0
1.2
2023-12
0
1
2024-03
0
1
2024-05
0
1
2024-10
0
1.5
2025-02
0
1
2025-04
0
1
2025-06
0
1
2025-08
0
1
2025-09
0
1
2025-10
0
2
2025-11
0
1
2025-12
0
1
2026-04
0
1
2026-06
0
1
This device (reports/month)Average device in MUJ (reports/device/month)
Regulatory clearances
K142108 SESE 2014-12-16 (k number procode)
Predicate lineage
K142108 — cites (transitively): K103246 (d1), K080886 (d2), K080888 (d2) — cited as predicate by K170750, K202284
Lineage extracted from public 510(k) summary text (heuristic).