Philips Volcano FFR software used in specific imaging systems connected to Hemodynamic Systems may cause interoperability issues. Affected units include Volcano s5i, s5ix, and CORE Mobile Imaging Systems with certain part numbers. No remedy is stated in the recall notice.
Interoperability issue that affects certain systems that use the recalled software when it is connected to specific Hemodynamic Systems (HMS).
Philips Volcano FFR software for certain imaging systems connected to Hemodynamic Systems (HMS) has been recalled due to interoperability issues. This could cause system malfunctions when used with specific HMS models. The recall does not include a remedy as stated in the official notice.
The software has interoperability issues when connected to certain Hemodynamic Systems (HMS), which could lead to system malfunctions. This may cause imaging procedures to fail or produce incorrect results during patient care.
Healthcare professionals using the recalled software with specific Hemodynamic Systems (HMS) are most at risk. Patients using these systems may experience potential disruptions in imaging procedures.
Check if your system includes the Volcano Imaging System s5i (Part #807400001), s5ix Imaging System (Part #807400001 R), or CORE Mobile Imaging Systems with specific part numbers listed in the recall notice. The software version is FFR V2.5 with Catalog numbers 4536-010-57091 or 4536-010-52781.
Verify if your system uses FFR V2.5 software with Catalog numbers 4536-010-57091 or 4536-010-52781.
The recall notice does not state any remedy or fix for the interoperability issue.
Affected systems include Volcano s5i, s5ix, and CORE Mobile Imaging Systems with specific part numbers listed in the recall notice.
Check your system's part number against the list provided in the recall notice, which includes specific models and part numbers for Volcano Imaging Systems and CORE Mobile Imaging Systems.
We’ve drafted a message you can send Volcano Corporation to request your refund or repair — edit it as you like.
Subject: Recall Z-0674-2020 — Volcano Corporation Volcano Corporation Hello, I own a Volcano Corporation that is covered by recall Z-0674-2020 from Volcano Corporation. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
