Z-0917-2022 Class III Ongoing
FDA device recall Z-0917-2022 was initiated by Volcano Corp on February 3, 2022 and is designated Class III. 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 pro… The recall status is ongoing. Affected quantity: 1358.
Recall Details
- Product Type
- Devices
- Report Date
- April 20, 2022
- Initiation Date
- February 3, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1358
Product Description
Reason for Recall
Distribution Pattern
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