Brilliance BigBore Radiology CT - 728244 recallZ-1493-2017 · Philips Medical Systems (Cleveland) Inc · initiated Feb 23, 2017

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%).

FDA root cause category: Software design

What the company is doing

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.

Recall details

Recall number

Z-1493-2017

Status

Terminated

Initiated by the company

Feb 23, 2017

Recalling firm

Philips Medical Systems (Cleveland) Inc

Quantity

67

Product code

JAK

FDA submissions

K033357

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.

Product description

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.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

• Brilliance CT Big Bore

  Philips Medical Systems Nederland B.V. · System, x-ray, tomography, computed
  7 recalls1 report