—#163255

Product

Brilliance 64 with 4.1.7 XX026 software version model number 728231 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 analysis and display equipment, patient and equipment supports, components, and accessories

FDA product code: JAK — System, X-Ray, Tomography, Computed
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K033326
Affected lot / code info: Serial numbers: . 9134 9667 9738 9788 9923 10773 95263 95669

Why it was recalled

Surview scan with tube current lower than 30 mA is unable to be initialized.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

On February 21, 2018 Philips Medical Systems sent a Customer Information Letter regarding the Philips Brilliance 64 Software Model 4.1.7. Customers were informed of how to identify affected products and instructed to use the Instructions For Use recommended 30mA for surview scans. Customers with questions or concerns should contact their local Philips representative or local Philips Healthcare office 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 Nationwide in the states of GA, VA, MI, AZ, and the countries of Canada, Switzerland

Timeline

Recall initiated: 2018-02-21
Terminated: 2020-04-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #163255. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.