Kent Imaging Inc
2 recall(s) on record — most severe on record: Class II.
Activity by year
- Recalls (2)
Devices registered here (1)
- Oximeter, Tissue SaturationProduct code MUD (opens in a new tab) · Class II · Cardiovascular · 21 CFR 870.2700
Recalls & enforcement
- Class IIOngoing2026-06-30The 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…
- Class IIOngoing2023-10-30Tissue oxygenation measurement system touchscreens may be unresponsive, which may prevent the viewing of oxygenation images.
Related
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Kent Imaging Inc (FEI 3009771004) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3009771004-kent-imaging-inc/
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