FDA DeviceClass IINotable

FDA Recall: SnapshotGLO Wound Imaging Device, Model KB100, KB100AA.

Date: 2026-07-29
Brand: KENT IMAGING, INC.
Category: Medical Device
FDA Class: Class II

Description

The software controlling the wound imaging device's battery charging circuit was not designed to recognize and recover a battery that has fully discharged into a low-power "shipping mode." When this occurs, an affected device will not resume charging when reconnected to power and becomes temporarily unusable/ unavailable for wound imaging until corrected.

Hazard

The software controlling the wound imaging device's battery charging circuit was not designed to recognize and recover a battery that has fully discharged into a low-power "shipping mode." When this occurs, an affected device will not resume charging when reconnected to power and becomes temporarily unusable/ unavailable for wound imaging until corrected.

Remedy

77

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