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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 96377

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

Open FDA event record

Event summary

Timeline bucket
April 07, 2025
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Philips Medical Systems Nederland B.V.

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

IntelliSpace Cardiovascular software versions 6.x, 7.x, and 8.x; Model Number: 830089.

Z-1740-2025
Recall number
Z-1740-2025
Initiated
April 07, 2025
Classification
Class II
Status
Ongoing
Quantity
996 units (267 US, 729 OUS)

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software when using the Echo Module of ISCV, the issue

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software in the Use Environment

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

An issue was identified with the software when using the Echo Module of ISCV, the issue may result in missing or incomplete information in the report.

Code information

Model Number: 830089; Software Versions: 6x, 7.x, and 8.x; UDI-DIs: (01)00884838106970(11)211130(10)6.1.0.0 (Version 6.1.0.0), (01)00884838106970(11)220623(10)6.2.0.0 (Version 6.2.0.0), (01)00884838115378(11)221214(10)7.0.0.0 (Version 7.0.0.0), (01)00884838115378(11)230711(10)7.1.0.0 (Version 7.1.0.0), (01)00884838122000(11)240325(10)8.0.0.0 (Version 8.0.0.0).

Distribution pattern

Domestic: Nationwide Distribution International: Australia, Austria, Belgium, Canada, Denmark, Estonia, Finland, France, Germany, Greece, Hong Kong, Indonesia, Ireland, Italy, Japan, Luxembourg, Mexico, Netherlands, Norway, Poland, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Thailand, United Kingdom.

Field note

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