Radiance · recalls, adverse events, clearances

Adverse-event reports (MAUDE)

Read this first: 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 shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.

2 linked reportsMalfunction 2

Monthly adverse-event reports for this device versus the product-code average.
Month	This device (reports)	Product-code average (reports per device)
2019-12	0	1
2020-01	0	1.67
2020-03	0	2
2020-05	0	4
2020-06	0	7
2020-07	0	11
2020-08	0	3.67
2020-09	0	5
2020-10	0	3.5
2020-11	0	7
2020-12	0	5
2021-01	0	6
2021-03	0	4
2021-04	0	9
2021-05	0	4
2021-06	0	5.5
2021-07	0	2
2021-08	0	1.5
2021-09	0	3
2021-10	0	6
2021-11	0	6
2021-12	0	2
2022-01	0	4
2022-02	0	6
2022-03	0	4.33
2022-04	0	8
2022-05	0	12
2022-06	0	4.5
2022-07	0	6
2022-09	0	3.5
2022-10	0	5
2022-11	0	3.67
2022-12	0	4
2023-01	0	2
2023-02	0	2
2023-03	0	5.5
2023-04	0	1
2023-05	0	1
2023-06	0	2
2023-07	0	2.75
2023-08	0	1
2023-09	0	5
2023-10	2	1.67
2023-12	0	6
2024-01	0	2
2024-02	0	1.5
2024-03	0	1.8
2024-05	0	4
2024-06	0	5.5
2024-07	0	2.67
2024-08	0	1
2024-09	0	4
2024-10	0	2
2024-11	0	2
2024-12	0	2
2025-06	0	1.5
2025-07	0	2.33
2025-08	0	1
2025-10	0	5
2025-11	0	2
2025-12	0	3
2026-01	0	8.83
2026-02	0	13.75
2026-03	0	15.14
2026-04	0	18.83
2026-05	0	7.67
2026-06	0	62.19

This device (reports/month)Average device in KQM (reports/device/month)

Failure-mode summaryAI-generated

2 linked report narratives available — no AI summary generated yet.

Recall history

No recalls linked.

Individual MAUDE reports

Date	Report #	Type	Narrative	Link basis
2023-10-16	3014991167-2023-00001	Malfunction	Available	exact di

Showing the most recent 1 of 2 linked reports.

Regulatory clearances

None linked.

Manufacturer compliance record

Date	Type	Outcome	Facility	Citations
2026-02-13	VAI	Voluntary action indicated	NDS Surgical Imaging LLC	1
2026-02-13	VAI	Voluntary action indicated	NDS Surgical Imaging LLC	1
2015-03-25	NAI	No action indicated	NDS Surgical Imaging LLC	1
2015-03-25	NAI	No action indicated	NDS Surgical Imaging LLC	1
2012-08-17	VAI	Voluntary action indicated	NDS Surgical Imaging LLC	4
2012-08-17	VAI	Voluntary action indicated	NDS Surgical Imaging LLC	4
2012-04-20	VAI	Voluntary action indicated	NDS Surgical Imaging LLC	1
2012-04-20	VAI	Voluntary action indicated	NDS Surgical Imaging LLC	1
2010-07-21	VAI	Voluntary action indicated	NDS Surgical Imaging LLC	1
2010-07-21	VAI	Voluntary action indicated	NDS Surgical Imaging LLC	1

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