SyncVision Systems, Model: 400-0100.10, PN: 30000485688x, with software version 4.2.x
Reported: April 13, 2022 Initiated: January 19, 2022 #Z-0885-2022
Product Description
SyncVision Systems, Model: 400-0100.10, PN: 30000485688x, with software version 4.2.x
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.
Details
- Recalling Firm
- Volcano Corporation
- Units Affected
- 3,216
- 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
- Location
- Rancho Cordova, CA
Frequently Asked Questions
What product was recalled? ▼
SyncVision Systems, Model: 400-0100.10, PN: 30000485688x, with software version 4.2.x. Recalled by Volcano Corporation. Units affected: 3,216.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 13, 2022. Severity: Moderate. Recall number: Z-0885-2022.
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