—#103269

Product

Brilliance iCT Computed Tomography X-Ray System, 510 (k) #K060937, Model #728306, Serial Numbers: 100019, 100023, 100087, 100103, and 100170. The recalled system units are equipped with operating software version; 3.2.0.19011. The Brilliance ICT and Brilliance ICT SP are Computed Tomo grapy 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: K060937
Affected lot / code info: Model #728306, Serial Numbers: 100019, 100023, 100087, 100103, and 100170

Why it was recalled

Software errors. Philips Medical's Field Service Engineers are installing software upgrades to certain of their Brilliance iCT and Brilliance ICT SP CT X-ray system units in order to correct non-conformances evidenced in these systems due to software errors.

Root cause (FDA determination)

Other

Action the firm took

Philips Medical ( Cleveland) Inc. indicated in the Correction and Removal Report dated June 21, 2011, that a Philips Field Service Engineer will be contacting each site in order to schedule a time to implement the Field Change Order. After which time, the Field Service Engineer will visit each customer site to install the software upgrade and the firm will be tracking the progress of this corrective action. For further questions please 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 (nationwide) including the states of DC, IL, IN, OH, PA and VT and the countries of Belgium and Israel.

Timeline

Recall initiated: 2011-06-15
Posted by FDA: 2011-09-14
Terminated: 2013-02-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #103269. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.