MM-TSM (Touch Screen Module/Secondary Controller/Bedside Controller), Part Numbers: 300002018101, 300002018102, used with IntraSight Integrated (Part Number: 797403) IVUS systems
- Company
- Volcano Corp
- Recall Initiated
- February 3, 2022
- Recall Number
- Z-0917-2022
- Quantity
- 1358
- Firm Location
- San Diego, CA
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
Lot / Code Info
MM-TSMs with bottom protective beams
Root Cause
Device Design
Action Taken
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