Device 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.
Z-1891-2018
Product summary
- Event
- Event 79715
- Status
- Terminated
- Classification
- Class II
- Quantity
- 8 devices
- Official record key
device-enforcement:Z-1891-2018
Official wording
Reason: The incorrect resistor has been used in affected CORE M2 Imaging Systems, which causes noise and results in an overly bright IVUS Image.
Code information: Serial #: 126620101597, 126620101599, 126620101600, 126620100718, 126620102313, 126620102315, 126620102307, and 126620093077.
Distribution pattern: Worldwide Distribution -- U.S., to the states of California, Connecticut, Tennessee, North Carolina, Maryland, and Oregon; and, the country of Australia.
Derived failure modes
-
Unknown
The incorrect resistor has been used in affected CORE M2 Imaging Systems, which causes noise and results in an overly bright IVUS Image.