Recall Z-2775-2026

Reason for recall

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.

FDA-determined cause: Software design

Action taken

On 6/30/2026, correction and removal notices were emailed to customers who were asked to do the following: 1) Discontinue use of the affected unit(s) and remove them from clinical service. 2) Contact Kent Imaging at customerservice@kentimaging.com to confirm return shipping instructions. 3) Pending return, keep the device charged and avoid allowing the battery to fully deplete, to prevent the unit from becoming temporarily inoperable in the interim. 4) Within 5 business days of receipt of this notice, please confirm receipt and current status of the listed unit(s) by replying to this letter or contacting Hitalo Arume directly. Distributor was asked to: a) Identify the current location/holder of each of these 6 units; b) Coordinate scheduling of a brief remote session between Kent Imaging's technical support team and each unit's user; and c) Confirm completion of each update on the attached Device Reconciliation Form. d) For units that require physical return, quarantine and stop distribution. For units distributed, identify each affected customer, coordinate on-site access for collection, and arrange return shipment to Kent Imaging. Questions can be directed to hitaloa@kentimaging.com