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.
Check against the official notice below — it lists the full affected range.
Volcano Corporation has recalled eight Philips Volcano CORE M2 Vascular Systems due to an incorrect resistor installed in the devices. This component defect causes noise and produces overly bright IVUS images, which are used to evaluate blood vessel structure in coronary arteries. The affected devices were distributed worldwide, including to California, Connecticut, Tennessee, North Carolina, Maryland, Oregon, and Australia.
The recalled units are identified by eight specific serial numbers: 126620101597, 126620101599, 126620101600, 126620100718, 126620102313, 126620102315, 126620102307, and 126620093077. The source document does not specify a remedy or corrective action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
The incorrect resistor has been used in affected CORE M2 Imaging Systems, which causes noise and results in an overly bright IVUS Image.
Reason for recall: The incorrect resistor has been used in affected CORE M2 Imaging Systems, which causes noise and results in an overly bright IVUS Image. Distribution: Worldwide Distribution -- U.S., to the states of California, Connecticut, Tennessee, North Carolina, Maryland, and Oregon; and, the country of Australia. Quantity: 8 devices Lot/code info: Serial #: 126620101597, 126620101599, 126620101600, 126620100718, 126620102313, 126620102315, 126620102307, and 126620093077.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.