RegWardenFDA facility compliance records
Recall

Class II — KENT IMAGING, INC.

Recalling firmKent Imaging Inc.
Registered facilityKent Imaging Inc (the firm's only registered facility)
ClassificationClass II
StatusOngoing
ReasonTissue oxygenation measurement system touchscreens may be unresponsive, which may prevent the viewing of oxygenation images.
ProductSnapshot NIR, REF: KD204
Quantity57
DistributionWorldwide - US Nationwide distribution in the states of IN, OH, TX, PA, WI, OR, CO, IL, MO, CA, AZ, IA and the countries of Malaysia.
Initiated2023-10-30
Classified2024-01-25
Recall numberZ-0789-2024
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — KENT IMAGING, INC. (Z-0789-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/93624/

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