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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 93363

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

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Event summary

Timeline bucket
October 09, 2023
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Philips North America

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

Spectral CT on Rails, Software Version 5.1.0, Model Number 728334

Z-0306-2024
Recall number
Z-0306-2024
Initiated
October 09, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Philips North America
Quantity
1 unit

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software crash. This would result in

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

When preparing for CCT Fluoroscopy mode and activating the CCT foot pedal simultaneously, the operator may experience a software crash. This would result in the system needing to be restarted.

Code information

UDI-DI: 00884838103627; Lot Code: 1005

Distribution pattern

US Nationwide distribution in the state of MN.