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U.S. Department of Health and Human Services

Class 2 Device Recall Snapshot NIR

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 Class 2 Device Recall Snapshot NIRsee related information
Date Initiated by FirmOctober 30, 2023
Date PostedJanuary 25, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0789-2024
Recall Event ID 93624
510(K)NumberK201976 
Product Classification Oximeter, tissue saturation - Product Code MUD
ProductSnapshot NIR, REF: KD204
Code Information 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
Recalling Firm/
Manufacturer		 KENT IMAGING, INC.
Suite 300, 1210 8 Street SW
Calgary Canada
Manufacturer Reason
for Recall		Tissue oxygenation measurement system touchscreens may be unresponsive, which may prevent the viewing of oxygenation images.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionOn 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 in Commerce57
DistributionWorldwide - US Nationwide distribution in the states of IN, OH, TX, PA, WI, OR, CO, IL, MO, CA, AZ, IA and the countries of Malaysia.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = MUD
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