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Infraredx Recalls

1 recall on record · January 11, 2017 to January 11, 2017 · Medical Devices

January 11, 2017Medical DevicesFDA

Infraredx, Inc. recalls TVC Imaging System model TVC-MC9 , for the near-infrared examination of coronary arteries in patients undergoing invasiv

Hazard: Near-infrared spectroscopic image (Chemogram) generated by the TVC Imaging System TVC-MC9 in some cases demonstrated an unusual appearance in that the yellow in the image (indicating the presence of lipid core plaques) was horizontally-oriented

Infraredx Recalls | RecallWatchUSA