Volcano Corp recalls MM-TSM touch screen modules used with IVUS systems that may crack, causing non-functionality. Affected units have specific part numbers and require replacement of protective beams.
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.
Volcano Corp is recalling MM-TSM touch screen modules that may crack or become damaged when used with IVUS systems, potentially making them non-functional. This could affect medical devices used in healthcare settings.
The MM-TSM modules may crack or become damaged, leading to non-functionality. This could disrupt medical device operations if the modules are critical for patient care.
Healthcare professionals using Volcano MM-TSM modules with IVUS systems are most at risk. Patients using these devices may be affected if the modules become non-functional.
Check for part numbers 300002018101 or 300002018102 on the MM-TSM modules. These are used with IntraSight Integrated IVUS systems (part number 797403).
Identify the part number on the MM-TSM module to confirm if it is affected (300002018101 or 300002018102).
Replace the bottom protective beams with full protective metal brackets as specified in the recall.
Part numbers 300002018101 and 300002018102.
The modules may crack or become damaged, causing non-functionality when used with IVUS systems.
No, but you should replace the protective beams as part of the recall remedy.
We’ve drafted a message you can send Volcano Corp to request your refund or repair — edit it as you like.
Subject: Recall Z-0917-2022 — Volcano Corp Volcano Corp Hello, I own a Volcano Corp that is covered by recall Z-0917-2022 from Volcano Corp. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
