FDA Recalls Touch Screen Modules for IVUS Imaging Systems
Volcano Corp is recalling MM-TSM touch screen modules used with IntraSight Integrated IVUS systems because they may crack or become damaged, potentially rendering the imaging equipment non-functional.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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: FDA Class III device with no reported illnesses or injuries. The recall is precautionary in nature, addressing potential cracking of a device component through replacement of protective elements. Class III recalls are typically low to moderate in severity.
Plain-English summary
Volcano Corp is recalling Multi-Modality Touch Screen Modules (MM-TSM) with part numbers 300002018101 and 300002018102, used with IntraSight Integrated (Part Number 797403) IVUS intravascular ultrasound systems. The touch screen controllers may crack or become damaged, which could affect their usability and render them non-functional.
Affected devices have been distributed across the United States and international locations. The recall affects 1,358 units that were distributed with original bottom protective beams.
To address this issue, Volcano Corp will replace the bottom protective beams with full protective metal brackets on affected units. Healthcare facilities using these systems should contact Volcano Corp or their device representative to arrange for the replacement of protective components.
The recalled product
- Product
- MM-TSM (Touch Screen Module/Secondary Controller/Bedside Controller), Part Numbers: 300002018101, 300002018102, used with IntraSight Integrated (Part Number: 797403) IVUS systems
- Manufacturer
- Volcano Corp
- Affected units
- 1,358
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)
- MM-TSMs with bottom protective beams
Distribution
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