Volcano Corporation Recall 89673
Description: SyncVision Systems, Model: 400-0100.10, PN: 30000485688x, with software version 4.2.x
Volcano Corporation Recall 89673 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0885-2022 |
| Event ID | 89673 |
| Event Description | SyncVision Systems, Model: 400-0100.10, PN: 30000485688x, with software version 4.2.x |
| Product Type | Devices |
| Distribution | US: WI, CA, CO, MO, ID, DC, LA, VA, KS, OK, GA, KY, IL, AZ, NY, IN, FL, TX, NC, OH, WA, OR, NM, MT, IA, MI, TN, MN, PA, AL, MA, WV, NV, NH, CT, NE, NJ, HI, AR, UT, MD, SC, MS, AK, DE OUS: JP, SA, GB, DE, PT, SG, PL, ZA, NL, MT, ES, IN, GR, EG, FI, HK, FR, NO, DK, BE, AT, IT, CO, KW, MX, PS, QA, CY, CA, TW, LV, SE, HR, SI, MY, KR, IL, TH, AU, BR, CL, SK, CH, LB, OM, ID, PK, IE, NZ, PR, RO, MM, AR, RS, RU, PA, KE, UZ |
| Quantity | 3,216 |
| Recall Reason | If FFR measurement(s) are made prior to an iFR/FFR co-registration/pullback in the same procedural session, this could result in incorrect iFR/FFR Co-Registration results to be displayed, that may cause users to mistakenly use incorrect measurements, leading to inappropriate patient treatment. Image acquisition and processing system operators manual to be updated to include workflow alternatives. |
| Device Classification | 20220413 |
| Device Code Info | All serial numbers, limited to cases when: The SyncVision runs the current supported software version 4.2.x, AND The secondary modality (IntraSight IVUS) runs software version 5.x. Device Identifier (DI): 00845225012434 |
| Center Classification Date | 20220406 |
| Recall Initiation Date | 20220119 |
| Recalling Firm | Volcano Corporation |
| Initial Notification | Letter |
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