Recall Z-0917-2022— Volcano Corp
Class III · Ongoing
Class III FDA medical device recall by Volcano Corp, initiated 2022-02-03. FDA's recall record names no specific 510(k) clearance for this event. Product: MM-TSM (Touch Screen Module/Secondary Controller/Bedside Controller), Part Numbers: 300002018101, 300002018102, used with IntraSight Integrated (Part Number: 797403) IVUS systems. Reason: Multi-Modality Touch Screen Modules (MM-TSM), used with integrated IVUS systems, may crack, or become damaged, which may affect their usability. They could become non-functional. Therefore, bottom protective beams will be replaced with full protective metal brackets..
- Recalling firm
- Volcano Corp
- Classification
- Class III
- Status
- Ongoing
- Initiated
- 2022-02-03
- Firm location
- San Diego, CA, United States
Product description
MM-TSM (Touch Screen Module/Secondary Controller/Bedside Controller), Part Numbers: 300002018101, 300002018102, used with IntraSight Integrated (Part Number: 797403) IVUS systems
Reason for recall
Multi-Modality Touch Screen Modules (MM-TSM), used with integrated IVUS systems, may crack, or become damaged, which may affect their usability. They could become non-functional. Therefore, bottom protective beams will be replaced with full protective metal brackets.
Data sourced from openFDA. This site is unofficial and independent of the FDA.