Volcano Corporation 2022-04-13 Health serious FDA
Health · FDA · Recall #FDA-Z-0885-2022
SyncVision Systems, Model: 400-0100.10, PN: 30000485688x, with software version 4.2.x Recall
Issued April 13, 2022 · Volcano Corporation
In April 2022, Volcano Corporation recalled the SyncVision Systems, Model: 400-0100.10, PN: 30000485688x, with software version 4.2.x, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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.
What you should do
- 1 Stop using SyncVision Systems, Model: 400-0100.10, PN: 30000485688x, with software version 4.2.x right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Volcano Corporation to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Volcano Corporation
- Category
- Health
- Recall date
- April 13, 2022
- Units affected
- Not reported
- Sold at
- 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,
- Recall number
- FDA-Z-0885-2022
- Made in
- United States
- Issuing agency
- FDA
In context
- Volcano Corporation has 1 recall in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 870th Health recall we've logged in 2022.