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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 93000

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

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Event summary

Timeline bucket
August 02, 2023
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Philips Healthcare

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

Incisive CT, software version 5.0

Z-2520-2023
Recall number
Z-2520-2023
Initiated
August 02, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Philips Healthcare
Quantity
140 systems

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software issues with compliance concerns to Subchapter J: Issue

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Radiation Control for Health and Safety Act

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Philips has identified three software issues with compliance concerns to Subchapter J: Issue 1: Coronary Computed Tomography Angiography (CTA) scan may not be triggered at the optimal time. Issue 2: Use of aborted surview for scan planning will result in deviation from intended scan area. Issue 3: Actual clinical scan with bariatric (Noah) couch will deviate from the intended scan area if surview scan length is greater than 1832mm.

Code information

software version 5.0

Distribution pattern

US Nationwide Distribution