Volcano Corp MM-TSM (Touch Screen Module/Secondary Controller/Bedside Controller), Part Numbers: 300002018101, 300002018102, used with IntraSight Integrated (Part Number: 797403) IVUS systems Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
MM-TSM (Touch Screen Module/Secondary Controller/Bedside Controller), Part Numbers: 300002018101, 300002018102, used with IntraSight Integrated (Part Number: 797403) IVUS systems
Brand
Volcano Corp
Lot Codes / Batch Numbers
MM-TSMs with bottom protective beams
Products Sold
MM-TSMs with bottom protective beams
Volcano Corp is recalling MM-TSM (Touch Screen Module/Secondary Controller/Bedside Controller), Part Numbers: 300002018101, 30 due to Multi-Modality Touch Screen Modules (MM-TSM), used with integrated IVUS systems, may crack, or become damaged, which may affect their usability. They . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
On 02/03/22, correction notices were sent to customers who were asked to do the following: Notify all affected system users within the facility of this recall. The updated bracket improves protection on all sides of the MM-TSM touch screen that will prevent issues, cosmetic concerns, and maintain device integrity. If you are a distributor or have forwarded affected device(s) to another end user, it is imperative that all end-users with affected devices receive this Important Product Notice. Complete and return the customer response form. Customers with additional questions are encouraged to contact their local recalling firm representative or customer service: Phone: 1-800-228-4728, Option 2, Email: igtd.remotesupport@philips.com, Hours of Operation: Monday - Friday 8:00AM 5:00PM PST
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, WY, DC
Page updated: Jan 10, 2026