- Recalling firm
- KENT IMAGING, INC.
- 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.
- Affected products (lot / model / serial)
- UDI-DI: B376KB1000, Software Revisions v4.2.0 and v4.1.3
- Units affected
- 77
- Distribution pattern
- US Nationwide distribution in the states of PA, IA, FL, TX, GA, NV, CA, UT, IN, DC, KS, IL, TN, AR, AZ.
- Firm location
- Calgary, N/A, Canada
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- N/A
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-2775-2026
- Recall initiated
- June 30, 2026
- FDA classification date
- July 22, 2026
- FDA report date
- July 29, 2026
- FDA event ID
- 99406
- Last updated on HTM Vibe
- August 4, 2026