Z-0789-2024Class II

Snapshot NIR, REF: KD204

Name: Z-0789-2024 Snapshot NIR, REF: KD204
Creator: Kent Imaging, Inc.
Published: 2023-10-30
License: https://open.fda.gov/license/

Kent Imaging Inc / initiated 2023-10-30 / Open, Classified / root cause: manufacturing process

FDA source

KENT IMAGING, INC. began a recall of Snapshot NIR, REF: KD204 on 2023-10-30. FDA classified it as Class II and gives the reason as "Tissue oxygenation measurement system touchscreens may be unresponsive, which may prevent the viewing of oxygenation images". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0789-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-10-30
Posted: 2024-01-25
Recalling firm: Kent Imaging Inc
Product: Snapshot NIR, REF: KD204
Product code: MUD Oximeter, Tissue Saturation
Reason for recall: Tissue oxygenation measurement system touchscreens may be unresponsive, which may prevent the viewing of oxygenation images.
Root cause tag: manufacturing process
FDA 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 in commerce: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0789-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0789-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-01-31	2024-01-25

Product code MUD

K201976Class IISnapshotNIRKent Imaging / cleared 2020-11-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)