Recall Z-0789-2024— KENT IMAGING, INC.

Name: FDA recall Z-0789-2024
Creator: U.S. Food and Drug Administration
Published: 2023-10-30

Class II · Ongoing

Class II FDA medical device recall by KENT IMAGING, INC., initiated 2023-10-30. It names one FDA 510(k) clearance: K201976. Product: Snapshot NIR, REF: KD204. Reason: Tissue oxygenation measurement system touchscreens may be unresponsive, which may prevent the viewing of oxygenation images..

Recalling firm: KENT IMAGING, INC.
Classification: Class II
Status: Ongoing
Initiated: 2023-10-30
Firm location: Calgary, N/A, Canada

510(k) clearances named in this recall

1 on FDA's record

K201976 — SnapshotNIRKent Imaging·cleared 2020-11-10

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Snapshot NIR, REF: KD204

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.