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.
This recall has been terminated (originally issued January 3, 2018).
- Recall Initiated
- January 3, 2018
- Terminated
- July 2, 2019
- Recall Number
- Z-0840-2018
- Quantity
- 11
- Firm Location
- Cleveland, OH
- Official Source
- View on FDA website ↗
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.
Distribution
Worldwide Distribution - US Nationwide
Lot / Code Info
Brilliance Big Bore Oncology CT, Model # 728243 Serial #s: 76025 76022 76024 76023 76016 76021 76008 76010 76002 76020 76011
Root Cause
Under Investigation by firm
Action Taken
Philips sent an Urgent Field Safety Notice Medical Device Correction letter dated January 2, 2018 to their customers. The letter identified the affected product problem and actions to be taken. For questions contact your local Philips representative or local Philips Healthcare office.