IntraSight Mobile IVUS Systems, Model: 797415, Part numbers: 300002018101, 300002018102
Summary
The FDA issued a Class III for IntraSight Mobile IVUS Systems, Model: 797415, Part numbers: 300002018101, 30000 by Volcano Corp. Reason: Multi-Modality Touch Screen Modules (MM-TSM), which are bedside/secondary control units, used as part of Mobile IVUS systems, are missing the followin.
Details
Source
Device Recall
External ID
Z-0901-2022
Action Date
2022-04-20
Status
Ongoing
Category
device
Product Description
IntraSight Mobile IVUS Systems, Model: 797415, Part numbers: 300002018101, 300002018102
Lot/Code Info: All MM-TSM units, Device Identifier (DI): 00845225012915
Quantity Affected: 47
Reason for Recall
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.
Distribution
US: CO, GA, MA, TX, AZ, NY, PA, CA, FL, MO, OR, MD, NC, TN OUS: JP, DE, GB, NL, IT
Type: Voluntary: Firm initiated
Recall Initiated: 2022-01-24
Company
San Diego, CA
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 137 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Volcano Corp has 6 FDA actions in our database, including 6 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Volcano Corp) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Volcano Corp have FDA actions?
Volcano Corp has 6 FDA actions in our database, including 6 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0901-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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