FDA Medical Device Recalls (openFDA)
KENT IMAGING, INC.: SnapshotGLO Wound Imaging Device, Model KB100, KB100AA.
- Recall number
- Z-2775-2026
- Recalling firm
- KENT IMAGING, INC.
- Product
- SnapshotGLO Wound Imaging Device, Model KB100, KB100AA.
- Status
- Open, Classified
- Initiated
- 2026-06-30
- Posted
- 2026-07-22
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Software design
- Action
- 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
- Quantity
- 77
- Distribution
- US Nationwide distribution in the states of PA, IA, FL, TX, GA, NV, CA, UT, IN, DC, KS, IL, TN, AR, AZ.
- Lot, serial or model codes
- UDI-DI: B376KB1000, Software Revisions v4.2.0 and v4.1.3
- 510(k) numbers
- ["K242669"]
- PMA numbers
- not on file
- Product code
- QJF
- Firm FEI
- 3009771004
- Firm city
- Calgary
- Firm state
- not on file
- Firm country
- Canada
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28