—#109268

Product

The Brilliance iCT and iCT SP are 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. The Brilliance iCT and iCT SP are used 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: K060937
Affected lot / code info: Brilliance iCT: Model# 728306 Brilliance iCT SP: Model# 728311

Why it was recalled

Philips is issuing a software update (version 3.2.4) to the Brilliance iCT and iCT SP systems currently running software version 3.2.0, 3.2.1 or 3.2.3, addressing a number of non-conformances. A review was conducted of all nonconformances that are fixed by the software upgrade. None of these nonconformances result in unacceptable hazards. The nonconformance documented below had the highest sc

Root cause (FDA determination)

Software design

Action the firm took

Philips sent an Urgent - Medical Device Correction letter dated May 8, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Philips Key Market representatives will distribute the letter internationally. Additionally, a Field Service Engineer will contact each site to schedule time to implement the Field Change Order. Customers were instructed to review the Release Document provided them with information about the software update, new feature and enhancements. For North America and Canada customers should contact the Customer Care Solutions Center (1-800-722-9377, option 5: Enter Side ID or follow the prompts. For questions regarding this recall call 440-483-4918.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution - USA including AL, CA, DC, DE, FL, GA, IA, IN, MA, MD, MN, MS, NC, NY, OH, OR, PA, TN, TX, VT, WA & WV and the countries of Argentina, Australia, Belgium, Brazil, Canada, China, Czech Republic, Denmark, EGYPT, France, Germany, Greece, Hungary, ICELAND, India, Indonesia, Israel, ISRAEL, Italy, Japan, Jordan, Lebanon, Netherlands, New Zealand, PHILIPPINES, POLAND, Portugal, Qatar, Russia, SINGAPORE, South Korea, SPAIN, SWEDEN, Switzerland, Taiwan, THAILAND, Turkey, UNITED KINGDOM & Uzbekistan.

Timeline

Recall initiated: 2012-05-07
Posted by FDA: 2012-06-08
Terminated: 2013-07-25
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #109268. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.