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U.S. Department of Health and Human Services

Class 2 Device Recall Brilliance 64 CT XRay System

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  Class 2 Device Recall Brilliance 64 CT XRay System see related information
Date Initiated by Firm March 07, 2011
Date Posted May 19, 2011
Recall Status1 Terminated 3 on February 22, 2013
Recall Number Z-2206-2011
Recall Event ID 58510
510(K)Number K033326  
Product Classification Computed Tomography X-Ray System - Product Code JAK
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.
Code Information 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.
Recalling Firm/
Manufacturer		 Philips Medical Systems (Cleveland) Inc
595 Miner Road
Cleveland OH 44143-2131
For Additional Information Contact
440-483-7000
Manufacturer Reason
for Recall		 A program software error in the algorithm produces image artifacts that could possibly lead to a misdiagnosis of patients who have small metal implants.
FDA Determined
Cause 2		 Other
Action 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.
Quantity in Commerce 10 units
Distribution Nationwide Distribution -- DC, IL, IN, MI, MO, NY, OH, OR, PA, TX, and VT.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JAK and Original Applicant = PHILIPS MEDICAL SYSTEMS, INC.
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