—#153825

Product

Brilliance BigBore Radiology CT - 728244 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.

FDA product code: JAK — System, X-Ray, Tomography, Computed
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K033357
Affected lot / code info: System Serial Number - 76001, 76005, 76007, 76009, 76013, 76014, 76017, 76018, 76019, System Serial Number - Unique Device Identifier 76058 (01)00884838059450(21)76058 76033 (01)00884838059450(21)76033 76048 (01)00884838059450(21)76048 76059 (01)00884838059450(21)76059 76015 (01)00884838059450(21)76015 76063 (01)00884838059450(21)76063 76066 (01)00884838059450(21)76066 76049 (01)00884838059450(21)76049 76040 (01)00884838059450(21)76040 76032 (01)00884838059450(21)76032 76061 (01)00884838059450(21)76061 76031 (01)00884838059450(21)76031 76006 (01)00884838059450(21)76006 76041 (01)00884838059450(21)76041 76035 (01)00884838059450(21)76035 76038 (01)00884838059450(21)76038 76065 (01)00884838059450(21)76065 76064 (01)00884838059450(21)76064 76053 (01)00884838059450(21)76053 76050 (01)00884838059450(21)76050 76060 (01)00884838059450(21)76060 76036 (01)00884838059450(21)76036 76056 (01)00884838059450(21)76056 76055 (01)00884838059450(21)76055 76037 (01)00884838059450(21)76037 76051 (01)00884838059450(21)76051 76044 (01)00884838059450(21)76044 76039 (01)00884838059450(21)76039 76012 (01)00884838059450(21)76012 76026 (01)00884838059450(21)76026 760016 (01)00884838059450(21)760016 760001 (01)00884838059450(21)760001 760005 (01)00884838059450(21)760005 760004 (01)00884838059450(21)760004 760003 (01)00884838059450(21)760003 760007 (01)00884838059450(21)760007 76072 (01)00884838059450(21)76072 76062 (01)00884838059450(21)76062 76043 (01)00884838059450(21)76043 760013 (01)00884838059450(21)760013 760014 (01)00884838059450(21)760014 76029 (01)00884838059450(21)76029 760010 (01)00884838059450(21)760010 76027 (01)00884838059450(21)76027 760011 (01)00884838059450(21)760011 760009 (01)00884838059450(21)760009 760006 (01)00884838059450(21)760006 76045 (01)00884838059450(21)76045 76054 (01)00884838059450(21)76054 76069 (01)00884838059450(21)76069 76034 (01)00884838059450(21)76034 76030 (01)00884838059450(21)76030 76047 (01)00884838059450(21)76047 76057 (01)00884838059450(21)76057 76028 (01)00884838059450(21)76028 76068 (01)00884838059450(21)76068 760012 (01)00884838059450(21)760012 760002 (01)00884838059450(21)760002

Why it was recalled

Philips identified a 4D CT pulmonary phase issue on Brilliance BigBore Oncology/Radiology CT with 4.2.0 software version through customer complaints. 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%).

Root cause (FDA determination)

Software design

Action the firm took

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.

Recalling firm

Firm: Philips Medical Systems (Cleveland) Inc
Address: 595 Miner Rd, Cleveland, Ohio 44143-2131

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2017-02-23
Terminated: 2019-02-26
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #153825. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.