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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 83919

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
November 07, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Volcano Corporation

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-0674-2020
Recall number
Z-0674-2020
Initiated
November 07, 2018
Classification
Class II
Status
Terminated
Recalling firm
Volcano Corporation
Quantity
3,667 units with software

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
issue that affects certain systems that use the recalled software

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

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)

Distribution pattern

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, Iceland, India, Ireland, Israel, Italy, Jordan, Japan, Korea, Republic of, Lebanon, Lithuania, Malaysia, Malta, Mexico, Netherlands, New Zealand, Norway, Pakistan, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Serbia, Sierra Leone, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, and United Kingdom.