Reported Dec 18, 2019 · Terminated
Philips Volcano FFR software used in the following systems connected to the McKesson, Schwarzer, and some Philips Xper…
Volcano Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Volcano Corporation · 2870 Kilgore Rd · Rancho Cordova, CA · 95670-6133
Is this the product you have?
Philips Volcano FFR software used in the following systems connected to the McKesson, Schwarzer, and some Philips Xper Hemodynamic Systems (HMS)
15 of 15 products
| Model / number | Product as published |
|---|---|
807400001 | (1) Volcano Imaging System s5i |
807400001 | (2) s5ix Imaging System with s5iz PC Workstation Refurbished, R and 807401200 |
806300003 | (3) s5i Imaging System |
5322466 | (4) s5i Imaging System |
807300001 | (5) s5x Imaging System |
| — | (6) s5x Imaging System Refurbished, Pat#807300001 R |
804200001 | (7) s5 Imaging System Refurbished, R |
400-0100.01 | (8) CORE Mobile Imaging System (120V) |
400-0100.01-R | (9) CORE Mobile Imaging System Refurbished |
400-0100.07 | (10) CORE Mobile Imaging System (240V) |
400-0100.07-R | (11) CORE Mobile Imaging System Refurbished |
400-0100.08 | (12) CORE Mobile Imaging System (100V) |
400-0100.08-R | (13) CORE Mobile Imaging System Refurbished |
400-0100.02 | and (14) CORE Imaging System |
400 | (15) CORE Integrated Imaging System Refurbished, 0100.02 R. |
- Lot codes and dates
- FFR V2.5 Software Kit, Catalog 4536-010-57091 (Legacy 435-0602.48) and FFR V2.5 Update Installation Disk, Catalog 4536-010-52781 (Legacy 435-0100.98)
- Amount recalled
- 3,667 units with software
Where it was sold
- Nationwide
Why it was recalled
Interoperability issue that affects certain systems that use the recalled software when it is connected to specific Hemodynamic Systems (HMS).
This product could cause temporary or reversible health problems — stop using it.
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