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Open, Classified

Snapshot NIR, REF: KD204

FDA Recall Z-0789-2024 · Posted 2024-01-25

Recalling FirmKENT IMAGING, INC.
Recall StatusOpen, Classified
Product CodeMUD
Date Initiated2023-10-30
Product Quantity57

Reason for Recall

Tissue oxygenation measurement system touchscreens may be unresponsive, which may prevent the viewing of oxygenation images.

Firm Action

On 10/30/23, recall notices were mailed and emailed to customers who were asked to do the following: Customers are asked to choose two ways to obtain replacement devices. Either the firm will ship replacement devices to customers and customers will ship affected devices back to the firm, or 2) Firm personnel will exchange devices through visit. Customer with questions can contact the firm via phone, 1-403-455-7610, or via their website, https://www.kentimaging.com/contact

Root Cause

Nonconforming Material/Component

Distribution Pattern

Worldwide - US Nationwide distribution in the states of IN, OH, TX, PA, WI, OR, CO, IL, MO, CA, AZ, IA and the countries of Malaysia.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K201976SnapshotNIRKent Imaging · 2020-11-10

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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