Z-0840-2018 Class II Terminated
FDA device recall Z-0840-2018 was initiated by Philips Medical Systems (Cleveland) Inc on Jan 3, 2018 and is designated Class II. 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… The recall status is terminated (terminated Jul 2, 2019). Affected quantity: 11.
Recall Details
- Product Type
- Devices
- Report Date
- Mar 14, 2018
- Initiation Date
- Jan 3, 2018
- Termination Date
- Jul 2, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11
Product Description
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.
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 Pattern
Worldwide Distribution - US Nationwide
Code Information
Brilliance Big Bore Oncology CT, Model # 728243 Serial #s: 76025 76022 76024 76023 76016 76021 76008 76010 76002 76020 76011
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0840-2018
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026