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.
FDA Recall Z-0840-2018 · Posted None
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Recalling FirmPhilips Medical Systems (Cleveland) Inc
Recall StatusTerminated
Product CodeJAK
Date Initiated2018-01-03
Date Terminated2019-07-02
Product Quantity11
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.
Firm Action
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.
Root Cause
Under Investigation by firm
Distribution Pattern
Worldwide Distribution - US Nationwide
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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