Volcano Intravascular Ultrasound Systems Recalled for Inaccurate FFR/iFR Values
Volcano Corporation is recalling s5/s5i/CORE Intravascular Ultrasound Systems due to a software issue that may cause inaccurate FFR/iFR values.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a software defect leading to inaccurate diagnostic values (FFR/iFR), which poses a risk of harm to patients through potential misdiagnosis or treatment decisions, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Volcano Corporation is recalling Volcano s5/s5i/CORE Intravascular Ultrasound Systems, including software versions 3.3 and 3.4 and v.3.4 software kits. The recall involves a total of 4,007 devices, all models, with part numbers 804200-002 and 804200-014.
The recall is due to a software issue where an inaccurate Fractional Flow Reserve (FFR) or instantaneous FFR (iFR) value could be calculated under certain circumstances. These systems are used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature.
The affected devices were distributed worldwide, including the United States, Europe, and various countries in Asia, Africa, and the Americas. Users should contact Volcano Corporation for further instructions regarding the software issue.
The recalled product
- Product
- Volcano s5/s5i/CORE Intravascular Ultrasound Systems with software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 software kits; Model s5. Radiology: The Volcano s5/s5i and CORE Series Intravascular Imaging and Pressure System is used for the…
- Manufacturer
- Volcano Corporation
- Affected units
- 4,007
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 (1)
- Model s5. Part numbers: 804200-002 and 804200-014
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 recalled by Volcano Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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