Z-2775-2026 Class II Ongoing

Recalled by KENT IMAGING, INC. — Calgary, N/A

FDA device recall Z-2775-2026 was initiated by KENT IMAGING, INC. on June 30, 2026 and is designated Class II. 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 o… The recall status is ongoing. Affected quantity: 77.

Recall Details

Product Type
Devices
Report Date
July 29, 2026
Initiation Date
June 30, 2026
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
77

Product Description

SnapshotGLO Wound Imaging Device, Model KB100, KB100AA.

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.

Distribution Pattern

US Nationwide distribution in the states of PA, IA, FL, TX, GA, NV, CA, UT, IN, DC, KS, IL, TN, AR, AZ.

Code Information

UDI-DI: B376KB1000, Software Revisions v4.2.0 and v4.1.3