—#111235

Product

The Brilliance 64 and Ingenuity CT are whole body 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. This device 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: System Code # 728231, Serial #s: 91003, 95157, 9654, 95130, and 95504 System Code # 728326, Serial #s: 300010, 300030, and 300018

Why it was recalled

1. The current system design of software version 4.0.0xx379 does not prevent the system from scanning if the dose level exceeds a set upper dose limit for CT Brain Perfusion scanning, which previous versions did. However, the current version does have the Dose Check (NEMA XR-25) feature, which provides dose notifications and alerts, but it is possible for the user to disable Dose Check after ente

Root cause (FDA determination)

Software design

Action the firm took

Philips Healthcare sent an URGENT - Medical Device Correction letter date July 18, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Phillips will be installing a software update version 4.0.0xx516. A Philips Service Engineer will contact the customer for implementation of the software update on the affected systems free of charge. For further information or support concerning this issue, customers may contact their local Philips representatives or Philips Healthcare office. For North America and Canada, they may also contact the Customer Care Solutions Center (1-800-722-9377, option 5) For questions regarding this recall call 440-483-7000.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution - USA including IN and OH, also, the countries of Australia, Belgium, China, Israel, and Sweden

Timeline

Recall initiated: 2012-07-18
Posted by FDA: 2012-08-17
Terminated: 2013-02-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #111235. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.