MM-TSM (Touch Screen Module/Secondary Controller/Bedside Controller), Part Numbers: 300002018101, 300002018102, used wit
Summary
The FDA issued a Class III for MM-TSM (Touch Screen Module/Secondary Controller/Bedside Controller), Part Numbe by Volcano Corp. Reason: Multi-Modality Touch Screen Modules (MM-TSM), used with integrated IVUS systems, may crack, or become damaged, which may affect their usability. They .
Details
Source
Device Recall
External ID
Z-0917-2022
Action Date
2022-04-20
Status
Ongoing
Category
device
Product Description
MM-TSM (Touch Screen Module/Secondary Controller/Bedside Controller), Part Numbers: 300002018101, 300002018102, used with IntraSight Integrated (Part Number: 797403) IVUS systems
Lot/Code Info: MM-TSMs with bottom protective beams
Quantity Affected: 1358
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.
Distribution
US: AZ, IL, NV, MI, FL, NC, AK, PA, WI, MN, CA, AR, NJ, TX, OR, NM, SD, CO, KY, LA, DE, MA, MT, MO, VA, AL, NY, WV, SC, IN, GA, IA, OH, UT, NH, MS, TN, OK, ID, MD, HI, RI, WY, DC, WA, KS, NE, ND, CT, VT. OUS: SK, IT, DK, GB, DE, SE, IN, KW, QA, PL, NL, CL, JP, BE, AU, FR, PF, PT, NZ, CA, ES, PK, CY, AT, IL, IE, CH, GR, SA, PS, LB, HK, IS, TH, AR, OM, AE, NO, ID, RO, RS, MM, ZA, SG
Type: Voluntary: Firm initiated
Recall Initiated: 2022-02-03
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-0917-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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