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ROBOT ROSA ONE (USA)

Model 3.1.1.0 · MEDTECH · DI 03760244032492

HAW — Neurological Stereotaxic Instrument · Class II · 21 CFR 882.4560

OLO — Orthopedic Stereotaxic Instrument · Class II · 21 CFR 882.4560

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 (3)

InitiatedRecall #ClassStatusReasonLink basis
2021-09-22Z-0118-2022Class IOpen, ClassifiedThe firm has become aware of a software anomaly affecting ROSA One 3.1 Brain application which led to the inaccurate placement of an electrode during surgery. The firm has received 3 global complaints related to the issue. An incorrect trajectory could result in serious injury or death if undetected during surgery.k number procode
2020-01-06Z-1150-2020Class IITerminatedSome cross-sectional images from the image acquisitions of the patients head may not be reconstructed/displayed properly in two and three dimension views when using ROSA Brain software, potentially compromising the surgery planning.k number procode
2020-01-06Z-1151-2020Class IITerminatedSome cross-sectional images from the image acquisitions of the patients head may not be reconstructed/displayed properly in two and three dimension views when using ROSA Brain software, potentially compromising the surgery planning.code info di

Adverse-event reports — MAUDE (300)

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.

Malfunction: 232 · Injury: 68

61319252019-01: 0 reports for this device; peer average 9.11/device2019-02: 0 reports for this device; peer average 9.71/device2019-03: 0 reports for this device; peer average 9.79/device2019-04: 0 reports for this device; peer average 11.87/device2019-05: 0 reports for this device; peer average 13.04/device2019-06: 0 reports for this device; peer average 13.02/device2019-07: 0 reports for this device; peer average 9.88/device2019-08: 0 reports for this device; peer average 7.49/device2019-09: 0 reports for this device; peer average 7.85/device2019-10: 1 reports for this device; peer average 7.27/device2019-11: 0 reports for this device; peer average 9.91/device2019-12: 2 reports for this device; peer average 10.08/device2020-01: 2 reports for this device; peer average 8.04/device2020-02: 19 reports for this device; peer average 9.15/device2020-03: 23 reports for this device; peer average 9.62/device2020-04: 10 reports for this device; peer average 9.53/device2020-05: 3 reports for this device; peer average 11.43/device2020-06: 13 reports for this device; peer average 8.71/device2020-07: 16 reports for this device; peer average 9.7/device2020-08: 5 reports for this device; peer average 8.58/device2020-09: 15 reports for this device; peer average 8.91/device2020-10: 25 reports for this device; peer average 9.9/device2020-11: 23 reports for this device; peer average 10.94/device2020-12: 9 reports for this device; peer average 9.27/device2021-01: 21 reports for this device; peer average 9.05/device2021-02: 20 reports for this device; peer average 9.77/device2021-03: 16 reports for this device; peer average 9.35/device2021-04: 13 reports for this device; peer average 8.9/device2021-05: 16 reports for this device; peer average 9.8/device2021-06: 13 reports for this device; peer average 11.37/device2021-07: 8 reports for this device; peer average 8.74/device2021-08: 2 reports for this device; peer average 10.53/device2021-09: 0 reports for this device; peer average 13/device2021-10: 0 reports for this device; peer average 8.34/device2021-11: 0 reports for this device; peer average 11.01/device2021-12: 1 reports for this device; peer average 7.44/device2022-01: 0 reports for this device; peer average 6.82/device2022-02: 0 reports for this device; peer average 7.95/device2022-03: 0 reports for this device; peer average 9.35/device2022-04: 0 reports for this device; peer average 6.39/device2022-05: 0 reports for this device; peer average 8.87/device2022-06: 1 reports for this device; peer average 9.36/device2022-07: 1 reports for this device; peer average 8.79/device2022-08: 1 reports for this device; peer average 8.72/device2022-09: 0 reports for this device; peer average 8.74/device2022-10: 0 reports for this device; peer average 11.56/device2022-11: 0 reports for this device; peer average 10.32/device2022-12: 0 reports for this device; peer average 10.44/device2023-01: 0 reports for this device; peer average 9.14/device2023-02: 0 reports for this device; peer average 8.45/device2023-03: 6 reports for this device; peer average 10.04/device2023-04: 1 reports for this device; peer average 10.25/device2023-05: 1 reports for this device; peer average 10.82/device2023-06: 0 reports for this device; peer average 12.34/device2023-07: 0 reports for this device; peer average 14.14/device2023-08: 2 reports for this device; peer average 13.16/device2023-09: 0 reports for this device; peer average 11.4/device2023-10: 0 reports for this device; peer average 10.8/device2023-11: 0 reports for this device; peer average 14.61/device2023-12: 0 reports for this device; peer average 12.27/device2024-01: 0 reports for this device; peer average 16.51/device2024-02: 0 reports for this device; peer average 12.43/device2024-03: 0 reports for this device; peer average 14.98/device2024-04: 0 reports for this device; peer average 13.44/device2024-05: 1 reports for this device; peer average 12.95/device2024-06: 0 reports for this device; peer average 12.52/device2024-07: 1 reports for this device; peer average 13.91/device2024-08: 0 reports for this device; peer average 18.98/device2024-09: 1 reports for this device; peer average 14.7/device2024-10: 1 reports for this device; peer average 18.36/device2024-11: 0 reports for this device; peer average 10.72/device2024-12: 1 reports for this device; peer average 10.63/device2025-01: 2 reports for this device; peer average 12.32/device2025-02: 0 reports for this device; peer average 13.73/device2025-03: 0 reports for this device; peer average 12.56/device2025-04: 1 reports for this device; peer average 13.77/device2025-05: 0 reports for this device; peer average 13.22/device2025-06: 0 reports for this device; peer average 16.69/device2025-07: 0 reports for this device; peer average 12.44/device2025-08: 0 reports for this device; peer average 10.63/device2025-09: 1 reports for this device; peer average 11.02/device2025-10: 0 reports for this device; peer average 10.7/device2025-11: 0 reports for this device; peer average 9.45/device2025-12: 0 reports for this device; peer average 8.85/device2026-01: 0 reports for this device; peer average 10.24/device2026-02: 0 reports for this device; peer average 8.24/device2026-03: 2 reports for this device; peer average 8.88/device2026-04: 0 reports for this device; peer average 7.34/device2026-05: 0 reports for this device; peer average 7.59/device2026-06: 0 reports for this device; peer average 5.85/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0109.11
2019-0209.71
2019-0309.79
2019-04011.87
2019-05013.04
2019-06013.02
2019-0709.88
2019-0807.49
2019-0907.85
2019-1017.27
2019-1109.91
2019-12210.08
2020-0128.04
2020-02199.15
2020-03239.62
2020-04109.53
2020-05311.43
2020-06138.71
2020-07169.7
2020-0858.58
2020-09158.91
2020-10259.9
2020-112310.94
2020-1299.27
2021-01219.05
2021-02209.77
2021-03169.35
2021-04138.9
2021-05169.8
2021-061311.37
2021-0788.74
2021-08210.53
2021-09013
2021-1008.34
2021-11011.01
2021-1217.44
2022-0106.82
2022-0207.95
2022-0309.35
2022-0406.39
2022-0508.87
2022-0619.36
2022-0718.79
2022-0818.72
2022-0908.74
2022-10011.56
2022-11010.32
2022-12010.44
2023-0109.14
2023-0208.45
2023-03610.04
2023-04110.25
2023-05110.82
2023-06012.34
2023-07014.14
2023-08213.16
2023-09011.4
2023-10010.8
2023-11014.61
2023-12012.27
2024-01016.51
2024-02012.43
2024-03014.98
2024-04013.44
2024-05112.95
2024-06012.52
2024-07113.91
2024-08018.98
2024-09114.7
2024-10118.36
2024-11010.72
2024-12110.63
2025-01212.32
2025-02013.73
2025-03012.56
2025-04113.77
2025-05013.22
2025-06016.69
2025-07012.44
2025-08010.63
2025-09111.02
2025-10010.7
2025-1109.45
2025-1208.85
2026-01010.24
2026-0208.24
2026-0328.88
2026-0407.34
2026-0507.59
2026-0605.85
This device (reports/month)Average device in HAW, OLO (reports/device/month)

Regulatory clearances

  • K182848 SESE 2019-03-22 (k number procode)
  • K182417 SESE 2019-02-07 (k number procode)

Predicate lineage

K182417 — cites (transitively): K172444 (d1), K151359 (d2), K101791 (d3), K101797 (d3), K001801 (d4), K023651 (d4), K092239 (d4), K991081 (d4), K002906 (d4), K042777 (d4), K060245 (d4) — cited as predicate by K200047, K200511, K242575

K182848 — cites (transitively): K151511 (d1), K101791 (d2), K101797 (d2), K133444 (d2), K001801 (d3), K023651 (d3), K092239 (d3), K991081 (d3), K002906 (d3), K042777 (d3), K060245 (d3), K050438 (d3) — cited as predicate by K192133, K192173, K221028

Lineage extracted from public 510(k) summary text (heuristic).

Manufacturer compliance record — MEDTECH

  • VAI 2022-06-30 Medtech LLC · 1 citations
  • VAI 2022-06-30 Medtech LLC · 1 citations