CLASS II Device recall · Reported 14 Mar 2018 · FDA Enforcement Report

Brilliance Big Bore Radiology CT recalled by Philips Medical Systems

Philips Medical Systems (Cleveland) is recalling Brilliance Big Bore Radiology CT with 4.2.0, distributed nationwide in the US. The recall was initiated on 3 Jan 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesBrilliance 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

Quantity recalled119

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0839-2018
FDA event ID: 79134
Recalling firm: Philips Medical Systems (Cleveland), Cleveland, OH
Classification: Class II
Status: Terminated
Recall initiated: 3 Jan 2018
FDA classified: 2 Mar 2018
Reported: 14 Mar 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Imaging Equipment

Timeline

3 Jan 2018	Recall initiated by company
2 Mar 2018	Classified by FDA	+58 days
14 Mar 2018	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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.

Where it was distributed

Worldwide Distribution - US Nationwide

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

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

Where was it sold?

Worldwide Distribution - US Nationwide

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 79134

This product is part of a recall event; the main page for the event is Brilliance Big Bore Oncology CTwith recalled by Philips Medical Systems.

Reported	Class	Recall	Company	Reason	Where
14 Mar 2018	CLASS II	Brilliance Big Bore Oncology CTwith recalled by Philips Medical Systems	Philips Medical Systems (Cleveland)	Device Malfunction	Nationwide

More recalls from Philips Medical Systems (Cleveland)

All 315

Reported	Class	Recall	Company	Reason	Where
24 Sep 2025Device	CLASS II	Pinnacle Radiation Therapy Planning System recalled	Philips Medical Systems (Cleveland)	Device Malfunction	Nationwide
13 Aug 2025Device	CLASS II	Pinnacle 3 with TumorLOC, (870258) Radiation Therapy Planning System recalled	Philips Medical Systems (Cleveland)	Device Malfunction	Nationwide
21 Sep 2022Device	CLASS II	Pinnacle3 Radiation Therapy Planning System recalled	Philips Medical Systems (Cleveland)	Other	21 states
13 Nov 2019Device	CLASS I	Forte Gamma Camera System is intended to produce images recalled	Philips Medical Systems (Cleveland)	Other	Nationwide
13 Nov 2019Device	CLASS I	Forte Gamma Camera System is intended to produce images recalled	Philips Medical Systems (Cleveland)	Other	Nationwide

Other Imaging Equipment recalls

All 2,336

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	Medline Convenience Kits containing BD ChloraPrep Clear recalled	Medline Industries	Packaging Defects	Nationwide
9 Sep 2026Device	CLASS II	Medline Convenience Kits: Ultrasound Breast Pack recalled	Medline Industries	Sterility	Nationwide
2 Sep 2026Device	CLASS II	Alphenix Models Infx-8000C Infx-8000F Infx-8000V This device recalled	Canon Medical System USA	Other	Nationwide
2 Sep 2026Device	CLASS II	Merge PACS and Merge OrthoPACS recalled by Merge Healthcare	Merge Healthcare	Labeling Errors	Nationwide
19 Aug 2026Device	CLASS II	Philips Azurion recalled by Philips Medical Systems	Philips Medical Systems Nederl	Potency & Assay