SyncVision Systems, Model: 400-0100.10, PN: 30000485688x, with software version 4.2.x
Check against the official notice below — it lists the full affected range.
Volcano Corporation is recalling SyncVision Systems Model 400-0100.10 with software version 4.2.x used in cardiac imaging procedures. The device can display incorrect iFR/FFR co-registration results if FFR measurements are taken before the co-registration/pullback procedure in the same session, potentially leading users to rely on wrong measurements and provide inappropriate patient treatment.
The recall affects 3,216 devices distributed across the United States and multiple countries internationally. The issue occurs specifically when the SyncVision runs software version 4.2.x and the secondary IntraSight IVUS modality runs software version 5.x. The source document does not specify what affected consumers should do in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. 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, Quantity: 3,216 Lot/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
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.