Brilliance Big Bore Radiology CT with 4.2.0 software recall: Software Issue
Brilliance Big Bore Radiology CT with 4.2.0 software version. Model #' 728244 Product Usage: Computed Tomography X-ray systems intended to produce…
Why was Brilliance Big Bore Radiology CT with 4.2.0 software recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models 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
- Product
- Brilliance Big Bore Radiology CT with 4.2.0 software version. Model #' 728244 Product Usage: Computed Tomography X-ray systems intended to produce…
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Quantity
- 119
- Distribution
- Worldwide Distribution - US Nationwide
- Recall date
- March 14, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)