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U.S. Department of Health and Human Services

Class 2 Device Recall Brilliance iCT Computed Tomography XRay System,

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  Class 2 Device Recall Brilliance iCT Computed Tomography XRay System, see related information
Date Initiated by Firm October 11, 2013
Date Posted November 15, 2013
Recall Status1 Terminated 3 on August 04, 2015
Recall Number Z-0335-2014
Recall Event ID 66601
510(K)Number K060937  
Product Classification System, x-ray, tomography, computed - Product Code JAK
Product Brilliance iCT Computed Tomography X-Ray System,


Product Usage:
The Brilliance iCT is a Computed Tomography X-Ray System 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 Model #728306, Serial #'s: 100016, 100018, 100019, 100020, 100021, 100022, 100023, 100024 and 100025.
Recalling Firm/
Manufacturer		 Philips Medical Systems (Cleveland) Inc
595 Miner Rd
Cleveland OH 44143-2131
For Additional Information Contact
440-483-7600
Manufacturer Reason
for Recall		 If the couch, with the footrest extension attached, is positioned where the table travel is within the bore of the gantry, and the user begins to lower the couch, the footrest extension can contact the gantry cover or come in contact with the user due to the length of the accessory.
FDA Determined
Cause 2		 Device Design
Action Philips sent an Urgent - Medical Device Correction letter dated October. 11, 2013, to their customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to discontinue the use of the footrest extension. Philips also, stated they will replace the old footrest extension with the current one in use. For questions contact your local Philips representative or local Philips Healthcare office.
Quantity in Commerce 9 units
Distribution Worldwide distribution: USA (nationwide) Distribution in the states of DC, GA, IL, IN, NY and OH and the countries: Germany, Israel and Netherlands.
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(CLEVELAND), INC.
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