FDA Recall Open, Classified

MM-TSM (Touch Screen Module/Secondary Controller/Bedside Controller), Part Numbers: 300002018101, 300002018102, used with IntraSight Integrated (Part Number: 797403) IVUS systems

Recall: Z-0917-2022 · Initiated February 3, 2022

Recall

Recall Number: Z-0917-2022
Event Number: 89698
Firm: Volcano Corp
FEI Number: 3008363989
Product Code: DSA
Status: Open, Classified
Root Cause: Device Design
Initiated: February 3, 2022
Address: 3721 Valley Centre Dr, Ste 500, San Diego, CA, 92130-3328

Description

Reason

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.

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: [email protected], Hours of Operation: Monday - Friday 8:00AM 5:00PM PST

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

Quantity

1358