Exact FDA event identifier

Event 87872

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

Open FDA event record

Event summary

Timeline bucket: April 13, 2021
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Philips North America Llc

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

BRILLIANCE VOLUME system - A Computed Tomography X-Ray System intended to produce images of the head and body. Model Number: 728306

Z-1774-2021

Recall number: Z-1774-2021
Initiated: April 13, 2021
Classification: Class II
Status: Terminated
Recalling firm: Philips North America Llc
Quantity: 2 units (1 US and 1 OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Cooling Unit (CLU) expelled out of a CT gantry of an iCT system may result in injury

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

Cooling Unit (CLU) expelled out of a CT gantry of an iCT system may result in injury

Code information

Serial Numbers: 100100, 100434

Distribution pattern

Worldwide distribution - US Nationwide distribution in the state of NV and the country of Japan.