Volcano s5i/s5ix/s5iz/CORE Intravascular Ultrasound Imaging recallZ-2044-2015 · Volcano Corp · initiated Sep 23, 2013
Class II Terminated All recalls posted in July 2015
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Volcano Corp or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
A limitation in interoperability between the Philips Xper Flex Cardia Physiomonitoring System and Volcano's sS/Si, Core, and ComboMap systems. This limitation may impact the calculation of Fraction Flow Reserve (FFR) within the Volcano System when the system is connected to the Xper Flex Cardia system via its aortic pressure auxiliary output.
FDA root cause category: Nonconforming Material/Component
What the company is doing
Volcano and Philips sent an Advisory Notice letter dated September 23, 2013 to all impacted customers. The letter identified the affected product, problem and actions to be taken. For question contact your Volcano and Philips representative.
Recall details
- Recall number
- Z-2044-2015
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Sep 23, 2013
- Posted by the FDA
- Jul 8, 2015
- Recalling firm
- Volcano Corp
- Quantity
- 227 total units - all models
- Product code
- IYO
- FDA submissions
- K123898
- Distribution
- Worldwide Distribution - US Nationwide and the countries of Belgium, United Kingdom, Denmark, Netherlands, Sweden, Iceland, France, Saudi Arabia, Australia, Philippines and Thailand.
Product description
Volcano s5i/s5ix/s5iz/CORE Intravascular Ultrasound Imaging and Pressure System; Product/Part numbers: s5i -806300-020 ; s5ix/s5iz - 807400-001; CORE - 400-0 I 00.02. Intravascular Imaging and Pressure System for evaluation of blood flow, perfusion and vascular structures.
Code information (models, lots, serial numbers)
Product/Part numbers: s5i -806300-020 ; s5ix/s5iz - 807400-001; CORE - 400-0 I 00.02. All software versions
Other devices under the same FDA submission
2 devices cleared under K123898 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- CORE Mobile System Medical Equipment 400-0100.07Philips Image Guided Therapy Corporation · System, Imaging, Pulsed Echo, Ultrasonic3 reports
- CORE Mobile System Medical Equipment 400-0100.01Philips Image Guided Therapy Corporation · System, Imaging, Pulsed Echo, Ultrasonic1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 71404).
- Z-2043-2015 · TerminatedVolcano s5/s5x/CORE Mobile Intravascular Ultrasound Imaging and Pressure System; Product/Part numbers: s5 - 804200-002 and 804200-014; s5x - 807300-001; CORE MOBILE - 400-0100.01. …
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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