—#151958

Product

Brilliance iCT 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 product code: JAK — System, X-Ray, Tomography, Computed
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K060937
Affected lot / code info: Model Number 728306; System Serial Number 100619 Rorot-45535-673-94382 SN26

Why it was recalled

Failure to correctly document the installation of four M12 Bolts into the system rotor.

Root cause (FDA determination)

Employee error

Action the firm took

Philips sent a Customer Information Letter to their customer. The letter identified the affected product, problem description and actions to be taken by customers. For further information or support concerning this issue, contact your local Philips representative or local Philips Healthcare office. For SUPPORT North America and Canada, contact the Customer Care Solutions Center (1-800-722-9377).

Recalling firm

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

Distribution

Distribution pattern: The one system was distributed in Canada. There were no government or US distribution.

Timeline

Recall initiated: 2016-11-25
Terminated: 2018-07-02
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #151958. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.