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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 79715

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

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Event summary

Timeline bucket
March 22, 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 CORE M2 Vascular System, Part # 400-0100.17, Rx Only. Used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature.

Z-1891-2018
Recall number
Z-1891-2018
Initiated
March 22, 2018
Classification
Class II
Status
Terminated
Recalling firm
Volcano Corporation
Quantity
8 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The incorrect resistor has been used in affected CORE M2 Imaging Systems, which causes noise and results in an overly bright IVUS Image.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

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Inspect official wording and provenance

Reason for recall

The incorrect resistor has been used in affected CORE M2 Imaging Systems, which causes noise and results in an overly bright IVUS Image.

Code information

Serial #: 126620101597, 126620101599, 126620101600, 126620100718, 126620102313, 126620102315, 126620102307, and 126620093077.

Distribution pattern

Worldwide Distribution -- U.S., to the states of California, Connecticut, Tennessee, North Carolina, Maryland, and Oregon; and, the country of Australia.