Volcano Corporation recalls Philips Volcano FFR software used in the following systems connected to the McKesson, Schwarzer, and some Philips Xper…

Recall date

November 7, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0674-2020

FDA classification

Class II

Brand / firm

Volcano Corporation

Sold / distributed

Distribution was nationwide. There was government/military distribution. Foreign distribution was made to Canada, Austria, Australia, Badajoz, Bahrain, Belgium, Brazil, Bulgaria, Chile, China, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong,…

Why it was recalled

Interoperability issue that affects certain systems that use the recalled software when it is connected to specific Hemodynamic Systems (HMS).

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Philips Volcano FFR software used in the following systems connected to the McKesson, Schwarzer, and some Philips Xper Hemodynamic Systems (HMS): (1) Volcano Imaging System s5i, Part #807400001; (2) s5ix Imaging System with s5iz PC Workstation Refurbished, Part#807400001 R and 807401200; (3) s5i Imaging System, Part#806300003; (4) s5i Imaging System, Part#5322466; (5) s5x Imaging System, Part#807300001; (6) s5x Imaging System Refurbished, Pat#807300001 R; (7) s5 Imaging System Refurbished, Part#804200001 R; (8) CORE Mobile Imaging System (120V), Part #400-0100.01; (9) CORE Mobile Imaging System Refurbished, Part #400-0100.01-R; (10) CORE Mobile Imaging System (240V), Part #400-0100.07; (11) CORE Mobile Imaging System Refurbished, Part #400-0100.07-R; (12) CORE Mobile Imaging System (100V), Part #400-0100.08; (13) CORE Mobile Imaging System Refurbished, Part #400-0100.08-R; and (14) CORE Imaging System, Part #400-0100.02; (15) CORE Integrated Imaging System Refurbished, Part#400 0100.02 R.