SyncVision Systems cardiac imaging measurement error in same-session workflow
SyncVision cardiac imaging systems may display incorrect measurements during same-session procedures if workflow steps are performed out of order, potentially affecting patient treatment.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II cardiac imaging device with a software workflow issue that presents a risk of harm through incorrect measurement-guided treatment. No injuries have been reported, fitting the 'risk-of-harm products where injury has not yet been reported' category.
Plain-English summary
Volcano Corporation is recalling certain SyncVision Systems cardiac imaging devices, Model 400-0100.10, PN 30000485688x, with software version 4.2.x when paired with IntraSight IVUS software version 5.x. A total of 3,216 units were distributed.
The devices may display incorrect measurement results under specific workflow conditions. When FFR (fractional flow reserve) measurements are obtained before iFR/FFR co-registration or pullback imaging in the same procedure, the system may show inaccurate iFR/FFR co-registration results.
Operators may use these incorrect measurements to make clinical decisions, potentially resulting in inappropriate patient treatment. No illnesses or injuries related to this issue have been reported.
Volcano Corporation is updating the Image Acquisition and Processing System Operators Manual to include workflow alternatives that prevent this error.
The recalled product
- Product
- SyncVision Systems, Model: 400-0100.10, PN: 30000485688x, with software version 4.2.x
- Manufacturer
- Volcano Corporation
- Hazard
- measurement-error
- device-malfunction
- treatment-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All serial numbers
Distribution
Distributed in 46 states:
- 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
Related recalls
Same category
- SevereMedline Convenience Kits with Syringes Recalled for Unapproved Design Changes
FDA (Devices) · 2026-07-01
- ModerateThuvera Laser Console Software Version 2.2 Recall Notice
FDA (Devices) · 2026-07-01
- HighStryker Neurovascular INZONE Detachment System battery drain
FDA (Devices) · 2026-07-01
- HighSurgify Halo surgical burr recalled for potential breakage risk
FDA (Devices) · 2026-07-01
- ModerateMedline Polycarbonate Syringes Recalled for Unapproved Design Changes
FDA (Devices) · 2026-07-01