—#99493

Product

Brilliance 64, Computed Tomography X-Ray System, Model Numbers: 728231 and 728326, including the Ingenuity CT. The recalled units are equipped with software versions: 3.5.21028 and 3.5.25028. 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: The following Serial Numbers of the Brilliance 64 (including Ingenuity CT) are subject to recall/software correction: 4003, 9745, 9875, 90135, 90169, 95414, 300003, 300004, 300005, and 300010.

Why it was recalled

A program software error in the algorithm produces image artifacts that could possibly lead to a misdiagnosis of patients who have small metal implants.

Root cause (FDA determination)

Other

Action the firm took

A 'Field Safety Notice - Urgent - Medical Device Correction' notification was sent to the firm's customers via Certified mail on 3/8/2011. The notification letter explains the nature of the Metal Artifact Reduction/Metal Artifact Correction software error; the Brilliance CT X-Ray systems subject to correction and how to identify them; and the circumstances under which this error can occur. It also asks that the user stop running the MAR application on any of the affected Brilliance systems identified with the recalled serial numbers and software versions alluded to in the medical device correction notification. Lastly, the notification states that Philips Medical will provide a solution that will fix the issue and the notification lists contact names; telephone numbers; and E-mail addresses which the customer can contact for further information concerning this device issue, or customer support assistance.

Recalling firm

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

Distribution

Distribution pattern: Nationwide Distribution -- DC, IL, IN, MI, MO, NY, OH, OR, PA, TX, and VT.

Timeline

Recall initiated: 2011-03-07
Posted by FDA: 2011-05-19
Terminated: 2013-02-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #99493. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.