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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 76021

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

Open FDA event record

Event summary

Timeline bucket
November 25, 2016
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Philips Medical Systems (Cleveland) Inc

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 iCT Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories

Z-1004-2017
Recall number
Z-1004-2017
Initiated
November 25, 2016
Classification
Class II
Status
Terminated
Quantity
1

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Failure to correctly document the installation of four M12 Bolts into the system rotor.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Failure to correctly document the installation of four M12 Bolts into the system rotor.

Code information

Model Number 728306; System Serial Number 100619 Rorot-45535-673-94382 SN26

Distribution pattern

The one system was distributed in Canada. There were no government or US distribution.