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Volcano Corporation recalls Philips Volcano CORE M2 Vascular System, Part # 400-0100.17, Rx Only. Used for the qualitative and quantitative evalu
Recalled May 23, 2018 · FDA recall Z-1891-2018 · Volcano
Hazard
The incorrect resistor has been used in affected CORE M2 Imaging Systems, which causes noise and results in an overly bright IVUS Image. · FDA Class II
Units
8 devices
Sold at
Worldwide Distribution -- U.S., to the states of California, Connecticut, Tennessee, North Carolina, Maryland, and Oregon; and, the country of Australia.
Description
The incorrect resistor has been used in affected CORE M2 Imaging Systems, which causes noise and results in an overly bright IVUS Image.
Product
Philips Volcano CORE M2 Vascular System, Part # 400-0100.17, Rx Only. Used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature.
Manufacturer(s)
Volcano Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →