FDA DeviceClass IINotable
FDA Recall: ARTIS Pheno VE30A and VE40A, Model 10849000
Description
During 3D acquisitions, lighter and darker patient images may be captured, which may result in less accurate 3D reconstruction. The variation of brightness is a result of a constant unregulated medium dose and the angular change of patient diameter caused by rotational acquisition. This may result in unintentional low-dose radiation exposure to a patient.
Hazard
During 3D acquisitions, lighter and darker patient images may be captured, which may result in less accurate 3D reconstruction. The variation of brightness is a result of a constant unregulated medium dose and the angular change of patient diameter caused by rotational acquisition. This may result in unintentional low-dose radiation exposure to a patient.
Remedy
73
Related Recalls
2026-05-06 · FDA_DEVICE
FDA Recall: Medline medical procedure kits, containing Medline Neuro Sponges (4077 in total), LAMINECTOMY, CRANI
Medline Industries, LP
2026-05-06 · FDA_DEVICE
FDA Recall: VACUUM BAG SU LARGE, Non-sterile specimen container, Model/Catalog Number: 68409SS
Milestone S.R.L.
2026-05-06 · FDA_DEVICE
FDA Recall: Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. PLASTICS
Medline Industries, LP
2026-05-06 · FDA_DEVICE
FDA Recall: WHILL Model F, with software versions before HMI: 2.23 / MC: 1.05; the device is an indoor/outdoor,
WHILL, INC.