Brilliance Big Bore Oncology CTwith 4.2.0 software recall: Software Issue
Brilliance Big Bore Oncology CTwith 4.2.0 software version. Model #' 728243 Product Usage: Computed Tomography X-ray systems intended to produce…
Why was Brilliance Big Bore Oncology CTwith 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 Oncology CT, Model # 728243 Serial #s: 76025 76022 76024 76023 76016 76021 76008 76010 76002 76020 76011
- Product
- Brilliance Big Bore Oncology CTwith 4.2.0 software version. Model #' 728243 Product Usage: Computed Tomography X-ray systems intended to produce…
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Quantity
- 11
- Distribution
- Worldwide Distribution - US Nationwide
- Recall date
- March 14, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)