Volcano Corp recalls IntraSight Mobile IVUS Systems Model 797415 with missing labeling for safety. Affected units include specific part numbers and device identifiers.
Multi-Modality Touch Screen Modules (MM-TSM), which are bedside/secondary control units, used as part of Mobile IVUS systems, are missing the following labeling information: Unique Device Identifier, Legal Manufacturer Information, Part Number, Rx Symbol, and Model Reference Information.
Volcano Corp is recalling IntraSight Mobile IVUS Systems Model 797415 due to missing critical labels on the Multi-Modality Touch Screen Modules. This could lead to improper use or safety issues if the device isn't properly identified.
The Multi-Modality Touch Screen Modules (MM-TSM) are missing required labeling information such as the Unique Device Identifier, Legal Manufacturer Information, Part Number, Rx Symbol, and Model Reference. This could cause confusion or improper use if the device isn't correctly identified.
Healthcare professionals using the IntraSight Mobile IVUS Systems are most at risk. Patients using these systems may also be affected if the device isn't properly labeled.
Check for the model number 797415 and part numbers 300002018101 or 300002018102. Also look for the Device Identifier (DI) 00845225012915 on the MM-TSM units.
Verify if the MM-TSM units have the required labels including Unique Device Identifier, Legal Manufacturer Information, Part Number, Rx Symbol, and Model Reference Information.
The Multi-Modality Touch Screen Modules (MM-TSM) are missing critical labeling information such as Unique Device Identifier, Legal Manufacturer Information, Part Number, Rx Symbol, and Model Reference Information.
Check if your MM-TSM units have the required labels. If missing, contact Volcano Corp for guidance.
Look for model number 797415 and part numbers 300002018101 or 300002018102. Also check for Device Identifier (DI) 00845225012915 on the MM-TSM units.
We’ve drafted a message you can send Volcano Corp to request your refund or repair — edit it as you like.
Subject: Recall Z-0901-2022 — Volcano Corp Volcano Corp Hello, I own a Volcano Corp that is covered by recall Z-0901-2022 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.
