Recall Z-0789-2024 ยท MUD Oximeter, Tissue Saturation
KENT IMAGING, INC.
Snapshot NIR, REF: KD204
| Date | Jan 25, 2024 (initiated Oct 30, 2023) |
| Status | Open, Classified |
| Reason | Tissue oxygenation measurement system touchscreens may be unresponsive, which may prevent the viewing of oxygenation images. |
| Root cause | Nonconforming Material/Component |
| 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 |
| Quantity | 57 |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K201976 | SnapshotNIR Kent Imaging, Nov 10, 2020 |