Class 3 Device Recall MultiModality Touch Screen Modules (MMTSM)

• Date Initiated by Firm: February 03, 2022
• Create Date: April 12, 2022
• Recall Status: Open, Classified
• Recall Number: Z-0917-2022
• Recall Event ID: 89698
• Product Classification: Cable, transducer and electrode, patient, (including connector) - Product Code DSA
• Product: MM-TSM (Touch Screen Module/Secondary Controller/Bedside Controller), Part Numbers: 300002018101, 300002018102, used with IntraSight Integrated (Part Number: 797403) IVUS systems
• Code Information: MM-TSMs with bottom protective beams
• Recalling Firm/ Manufacturer: Volcano Corp; 3721 Valley Centre Dr Ste 500; San Diego CA 92130-3328
• For Additional Information Contact: Emily Dentler; 619-380-1318
• Manufacturer 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.
• FDA Determined Cause: Device Design
• Action: 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
• Quantity in Commerce: 1358
• 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
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.