Volcano Cardiology Imaging Systems Recalled for Network Compatibility Reboot Issue
Volcano Corporation is recalling specific cardiology imaging systems due to a software incompatibility that can cause unexpected reboots when encountering specific hospital network data.
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 2/5 (Moderate).
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. The hazard involves a software incompatibility causing system reboots, which is a functional defect without reported injuries or fatalities, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Volcano Corporation is recalling Volcano s5, s5i, CORE, and CORE Mobile systems equipped with software version 3.4 and v3.4 software kits. These systems are used for the qualitative and quantitative evaluation of vascular morphology in coronary arteries and peripheral vasculature. The recall affects 5,875 units, with 2,685 located in the United States and 3,190 distributed in other countries worldwide.
The recall is due to an incompatibility issue between the impacted systems and hospital network scans. In specific circumstances, the systems may encounter unexpected data from the hospital network, which forces the system to reboot. This issue is a software defect that affects the stability of the device during network interactions.
The affected systems were distributed nationwide in the US and in numerous countries including Japan, Germany, France, India, and others. Volcano Corporation is the recalling firm. Users of these systems should contact Volcano Corporation for further instructions on resolving the software incompatibility issue.
The recalled product
- Product
- Volcano s5, s5i, CORE and CORE Mobile systems with software version 3.4 and v3.4 software kits. Cardiology: The Volcano Universal (Core /Core Mobile), S5iz Platform Imaging System is used for the qualitative and quantitative evaluation of vascular morphology in the coronary…
- Manufacturer
- Volcano Corporation
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 (20)
- Systems with software version 3.2.x
- 3.3
- and 3.4 and v3.4 software kits. Product Codes: 807300001-807300001-R
- 804200001-E
- 807300001-E
- 807400001
- 804200001
- 806300001
- 1807400001
- 804200015
- 804200001-M
- 807400001-R
- 07300001-M
- 807300015-J
- 804200014-R
- 804200014
- 807400010
- 804200001-R
- 806300001-R
- 807300015-RF
Distribution
Distributed nationwide across the United States.
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