Philips Volcano CORE M2 Vascular System (Part #400-0100.17) with specific serial numbers recalled due to incorrect resistor causing overly bright IVUS images. Affected units may show inaccurate vascular imaging results.
The incorrect resistor has been used in affected CORE M2 Imaging Systems, which causes noise and results in an overly bright IVUS Image.
Philips Volcano CORE M2 Vascular System units with specific serial numbers were recalled because an incorrect resistor causes overly bright IVUS images. This could lead to inaccurate vascular imaging results for medical use.
The incorrect resistor in the affected units causes the IVUS (intravascular ultrasound) images to appear overly bright. This can lead to inaccurate vascular morphology evaluations, potentially affecting medical decisions about blood vessel health.
Healthcare professionals using the Philips Volcano CORE M2 Vascular System for vascular imaging are most at risk. Patients receiving these scans may experience inaccurate results due to the faulty imaging.
Check for the serial numbers: 126620101597, 126620101599, 126620101600, 126620100718, 126620102313, 126620102315, 126620102307, and 126620093077. The product is a Philips Volcano CORE M2 Vascular System used for vascular imaging in medical settings.
Verify if your unit has one of the listed serial numbers: 126620101597, 126620101599, 126620101600, 126620100718, 126620102313, 126620102315, 126620102307, or 126620093077.
The incorrect resistor in affected units causes overly bright IVUS images, which can lead to inaccurate vascular imaging results.
Check if your unit has one of the listed serial numbers. If it does, contact Philips Volcano for further instructions.
The recall record does not specify a remedy or fix.
We’ve drafted a message you can send Volcano to request your refund or repair — edit it as you like.
Subject: Recall Z-1891-2018 — Volcano Volcano Hello, I own a Volcano that is covered by recall Z-1891-2018 from Volcano. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
