Snapshot NIR Tissue Oxygenation System Touchscreens May Be Unresponsive
Kent Imaging's Snapshot NIR tissue oxygenation measurement system touchscreens may become unresponsive, preventing users from viewing diagnostic oxygenation images. Fifty-seven units have been distributed across multiple US states and Malaysia.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall for a functional defect (unresponsive touchscreen) that prevents proper use of a diagnostic imaging device, meeting the rubric criterion for risk-of-harm products where injury has not yet been reported. No illnesses or injuries have been documented.
Plain-English summary
The Snapshot NIR tissue oxygenation measurement system (model KD204) manufactured by Kent Imaging, Inc. is being recalled due to potential touchscreen unresponsiveness.
The device's touchscreen may become unresponsive, which prevents users from viewing tissue oxygenation images generated by the system. This defect could impair proper use of the device for diagnostic purposes.
Fifty-seven units have been distributed in the United States across Indiana, Ohio, Texas, Pennsylvania, Wisconsin, Oregon, Colorado, Illinois, Missouri, California, Arizona, and Iowa, as well as in Malaysia.
The recalled product
- Product
- Snapshot NIR, REF: KD204
- Manufacturer
- KENT IMAGING, INC.
- Affected units
- 57
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- UDI-DI: B376KD2040
- Serial Numbers: 204TUC1001
- 204TUC1002
- 204TUC1003
- 204TUC1004
- 7204TUC1005
- 204TUC1006
- 204TUC1007
- 204TUC1008
- 204TUC1009
- 204TUC1010
- 204TUC1011
- 204TUC1012
- 204TUC1013
- 204TUC1014
- 204TUC1015
- 204TUC1024
- 204TUC1025
- 204TUC1026
- 204TUC1028
Distribution
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