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Hermia

Hermes Medical Solutions AB · Model 00859873006226 · UDI-DI 00859873006226

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510(k) clearances

19,695

Adverse events (41 deaths)

560

Recalls

632

Facilities

Description

Voxel Dosimetry is a software application for nuclear medicine. Based on user input, Voxel Dosimetry calculates a volumetric map of the distribution of absorbed radiation dose (a dose map) on the voxel level for patients who have been administered with radioisotopes. Voxel Dosimetry presents the results to the user and the result can be stored for future analysis. The software application can be configured based on user needs. The intended users of Voxel Dosimetry are medical professionals trained in using the system. Voxel Dosimetry is intended for patients of any age and gender undergoing radionuclide therapy. Voxel Dosimetry is only intended for calculating dose for FDA approved radiopharmaceuticals. Voxel Dosimetry should not be used to deviate from approved product dosing and administration instructions. Refer to the product's prescribing information for instructions.

Recalls

Date	Firm	Reason
2026-07-31	GE Healthcare	Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be
2026-07-31	GE Healthcare	Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be
2026-07-31	GE Healthcare	Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be
2026-07-31	GE Healthcare	Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be
2026-07-31	GE Healthcare	Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be
2026-07-31	GE Healthcare	Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be
2026-07-22	FUJIFILM Healthcare Americas Corporation	Software issue may cause the ruler measurement to be inaccurate.
2026-07-22	Merge Healthcare, Inc.	Software issue may cause measurements to be displayed inaccurately.
2026-06-30	Merge Healthcare, Inc.	Merge Healthcare has identified a potential issue that may cause thumbnails from a previously opened patient study to be displayed in the Thumbnail Bar while a different patient st
2026-06-30	Merge Healthcare, Inc.	Merge Healthcare has identified a potential issue that may cause thumbnails from a previously opened patient study to be displayed in the Thumbnail Bar while a different patient st

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.