Volcano CORE M2 Vascular System Recalled for Incorrect Resistor
Volcano Corporation is recalling eight Philips Volcano CORE M2 Vascular Systems because an incorrect resistor causes noise and overly bright images.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the defect results in image quality issues (noise and brightness) rather than a direct physical injury or death, fitting the criteria for moderate severity.
Plain-English summary
Volcano Corporation is recalling eight units of the Philips Volcano CORE M2 Vascular System, Part # 400-0100.17. This prescription-only medical device is used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature.
The recall is due to the use of an incorrect resistor in the affected systems. This defect causes noise and results in an overly bright IVUS (Intravascular Ultrasound) image. The agency has classified this recall as Class II.
The affected devices were distributed worldwide to the United States (specifically California, Connecticut, Tennessee, North Carolina, Maryland, and Oregon) and Australia. The specific serial numbers for the eight affected units are 126620101597, 126620101599, 126620101600, 126620100718, 126620102313, 126620102315, 126620102307, and 126620093077.
The recalled product
- 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
- Volcano Corporation
- Category
- Medical Device — Imaging System
- Hazard
- Affected units
- 8
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (8)
- Serial #: 126620101597
- 126620101599
- 126620101600
- 126620100718
- 126620102313
- 126620102315
- 126620102307
- and 126620093077.
Distribution
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