—#96631

Product

Brilliance 64 S/N 9089, 9551, 9548. The Brilliance 64 is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.

FDA product code: JAK — System, X-Ray, Tomography, Computed
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K033326
Affected lot / code info: Model #728231, S/N 9089, 9551, 9548.

Why it was recalled

During the version 2.6 software upgrade, the system was not recalibrated with the infant phantom for the infant protocol.

Root cause (FDA determination)

Other

Action the firm took

Philips sent an URGENT - Medical Device Correction letter dated January 31, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers may consider reviewing any infant images that may have been affected during the Field Test to confirm reading accuracy. For further information or support concerning this issue, customers could contact their local Philips representative or local Philips Healthcare office for North America and Canada contact the Customer Care Solutions Center (1-800-722-9377, option 5: Enter Site ID or follow the prompts)

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution - USA including CO, IN, and TN and the countries of Norway, Israel, and Germany

Timeline

Recall initiated: 2010-12-20
Posted by FDA: 2011-03-24
Terminated: 2013-02-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #96631. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.