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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 79134

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
January 03, 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

2 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 2

Brilliance Big Bore Radiology CT with 4.2.0 software version. Model #' 728244 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-0839-2018
Recall number
Z-0839-2018
Initiated
January 03, 2018
Classification
Class II
Status
Terminated
Quantity
119

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
Software issues including: Software errors that may 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

Software issues including: Software errors that may result in Extended Field of View check message not displayed when Field of View is set >600 mm for a paused scan; Request for change to automatically turn on the center x/y 0 setting and the disable result rotation setting when turning on the CT simulation Exam Card; Software errors that may result in Tumor LOC allowing POI (Point of Interest) locking when a non-isocenter slice is displayed; Software errors that may result in partial set of images or inability to generate CT images.

Code information

Brilliance Big Bore Radiology CT with 4.2.0 software version. Model #' 728244 Serial #s: 76009 76030 76034 76007 76013 76014 76028 76047 76045 76073 76054 76077 76079 76069 76052 76083 76104 76082 76068 76100 76081 76092 76103 76097 76105 76043 76062 760007 76037 76090 76035 76004 76036 76072 76005 76015 760011 76033 76018 76019 76060 76056 76044 76094 76066 76038 76049 76046 76040 76085 76042 76003 76041 76058 76026 76059 76001 760015 76012 760001 76017 76048 76063 76050 76051 76039 76032 76029 76055 76065 76061 760006 76027 76053 760005 760003 76067 76057 760002 760016 76031 760019 760004 76006 76091 76070 760009 760008 760010 760012 760013 760014 760017 760018 76064 76088 76078 76107 76087 76080 76076 76075 76102 760021 76093 76095 760022 760020 76101 76074 76086 76084 76108 76071 76089 760023 760024 760025 760026

Distribution pattern

Worldwide Distribution - US Nationwide

device · product 2 of 2

Brilliance Big Bore Oncology CTwith 4.2.0 software version. Model #' 728243 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-0840-2018
Recall number
Z-0840-2018
Initiated
January 03, 2018
Classification
Class II
Status
Terminated
Quantity
11

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
Software issues including: Software errors that may 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

Software issues including: Software errors that may result in Extended Field of View check message not displayed when Field of View is set >600 mm for a paused scan; Request for change to automatically turn on the center x/y 0 setting and the disable result rotation setting when turning on the CT simulation Exam Card; Software errors that may result in Tumor LOC allowing POI (Point of Interest) locking when a non-isocenter slice is displayed; Software errors that may result in partial set of images or inability to generate CT images.

Code information

Brilliance Big Bore Oncology CT, Model # 728243 Serial #s: 76025 76022 76024 76023 76016 76021 76008 76010 76002 76020 76011

Distribution pattern

Worldwide Distribution - US Nationwide