FDA Device recall Z-0885-2022
SyncVision Systems, Model: 400-0100.10, PN: 30000485688x, with software version 4.2.x
- FDA Device
- Class II
- ongoing
- Published 2022-04-13
On 2022-04-13 the FDA classified a Class II recall of SyncVision Systems, Model: 400-0100.10, PN: 30000485688x, with software version 4.2.x by Volcano, citing 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 di….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0885-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-01-19 |
| Published | 2022-04-13 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Volcano |
| Distribution | AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, TN, TX, UT, VA, WA, WI, WV |
Product
SyncVision Systems, Model: 400-0100.10, PN: 30000485688x, with software version 4.2.x
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.
Identifiers
| code_info | All serial numbers, limited to cases when: The SyncVision runs the current supported software version 4.2.x, AND The…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0885-2022%22
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