Snapshot NIR, REF: KD204
FDA device recall Z-0789-2024 · posted 2024-01-25 · Open, Classified
Recall details
- Recalling firm
- KENT IMAGING, INC.
- Reason for recall
- Tissue oxygenation measurement system touchscreens may be unresponsive, which may prevent the viewing of oxygenation images.
- Action taken
- 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
- Status
- Open, Classified
- Product code
- MUD
- Quantity affected
- 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.
- Date initiated
- 2023-10-30
- Date posted
- 2024-01-25
- Location
- Calgary, Canada
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SnapshotNIR (K201976) | Kent Imaging | 2020-11-10 |