—#130286

Product

Philips Brilliance iCT Computed Tomography X-Ray System Product Usage: The Brilliance iCT/Brilliance iCT SP is a Computed Tomography X-Ray System intended to produce crosssectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. (d) A description of the defect in the

FDA product code: JAK — System, X-Ray, Tomography, Computed
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K060937
Affected lot / code info: Software version 4.1.

Why it was recalled

It was discovered that a software defect may result in the scanner not terminating the CT scan at the intended location.

Root cause (FDA determination)

Radiation Control for Health and Safety Act

Action the firm took

Philips Healthcare is directly notifying affected users via letter. In addition, Philips Healthcare has performed the software correction for forward production and plans a Field Correction to fix the defect in the field. If you need any further information or support concerning this issue, please contact your local Philips representative or local Philips Healthcare office.

Recalling firm

Firm: Philips Medical Systems, Inc.
Address: 3000 Minuteman Rd, Andover, Massachusetts 01810-1032

Distribution

Distribution pattern: US Distribution

Timeline

Recall initiated: 2014-07-31
Posted by FDA: 2014-12-16
Terminated: 2017-02-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #130286. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.