Snapshot NIR, REF: KD204
This recall is currently active, issued January 25, 2024. It was issued by Kent Imaging, Inc..
- Company
- Kent Imaging, Inc.
- Recall Initiated
- October 30, 2023
- Posted
- January 25, 2024
- Recall Number
- Z-0789-2024
- Quantity
- 57
- Firm Location
- Calgary Canada
- Official Source
- View on FDA website ↗
Reason for Recall
Tissue oxygenation measurement system touchscreens may be unresponsive, which may prevent the viewing of oxygenation images.
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.
Lot / Code Info
UDI-DI: B376KD2040, Serial Numbers: 204TUC1001, 204TUC1002, 204TUC1003, 204TUC1004, 7204TUC1005, 204TUC1006, 204TUC1007, 204TUC1008, 204TUC1009, 204TUC1010, 204TUC1011, 204TUC1012, 204TUC1013, 204TUC1014, 204TUC1015, 204TUC1024, 204TUC1025, 204TUC1026, 204TUC1028, 204TUC1029, 204TUC1033, 204TUC1036, 204TUC1038, 204TUC1040, 204TUC1041, 204TUC1042, 204TUC1043
Root Cause
Nonconforming Material/Component
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