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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 79759

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

Open FDA event record

Event summary

Timeline bucket
February 21, 2018
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 64 with 4.1.7 XX026 software version model number 728231 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 analysis and display equipment, patient and equipment supports, components, and accessories

Z-1396-2018
Recall number
Z-1396-2018
Initiated
February 21, 2018
Classification
Class II
Status
Terminated
Quantity
291

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Surview scan with tube current lower than 30 mA is unable to be initialized.

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

Surview scan with tube current lower than 30 mA is unable to be initialized.

Code information

Serial numbers: . 9134 9667 9738 9788 9923 10773 95263 95669

Distribution pattern

Worldwide Distribution - US Nationwide in the states of GA, VA, MI, AZ, and the countries of Canada, Switzerland