Brilliance BigBore Oncology CT - 728243 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 information may be used by a trained healthcare professional as a diagnostic tool for the visualization and analysis of anatomical and pathological structures.
This recall has been terminated (originally issued February 23, 2017).
- Recall Initiated
- February 23, 2017
- Terminated
- February 26, 2019
- Recall Number
- Z-1492-2017
- Quantity
- 11
- Firm Location
- Cleveland, OH
- Official Source
- View on FDA website ↗
Reason for Recall
When the user performs a retrospective respiratory gated 4D CT scan with the Bellows pulmonary gating device, the CT images might be reconstructed at a single phase, while the annotations on the images incorrectly indicate that the reconstruction is from the requested specific phases (0% to 90%).
Distribution
Worldwide Distribution - US to AR, CA, CO, CT, FL, GA, IL, IN, KY, LA, MA, MD, MI, MO, NC, NE, NJ, NM, NY, OH, TX & WI; Internationally to the following countries: Australia, Austria, Canada, China, Czech Republic, Germany, India, Israel, Jordan, Korea, Mexico, New Cldonia, Romania, Russian Federation, Turkey, & United Kingdom.
Lot / Code Info
System Serial Number - 76002, 76008, 76010, 76011, 76016, 76020, 76021, 76022, 76023, 76024, 76025
Root Cause
Software design
Action Taken
Philips sent an Urgent Field Safety Notice dated February 24, 2017, to all affected consignee's via certified mail with returned receipts for tracking purposes. Philips Key Market representatives will distribute the notices internationally. A Field Service Engineer will contact each site to schedule a time to implement the Field Change Order. Implementation of the software update will be monitored. Consignees requiring further information or support concerning this issue were instructed to contact their local Philips representative. For North America and Canada, contact the Customer Care Solutions Center at 1-800-722-9377.