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U.S. Department of Health and Human Services

Class 2 Device Recall Computed Tomography Xray systems Brilliance iCT

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  Class 2 Device Recall Computed Tomography Xray systems Brilliance iCT see related information
Date Initiated by Firm February 05, 2015
Date Posted July 24, 2015
Recall Status1 Terminated 3 on June 26, 2018
Recall Number Z-2255-2015
Recall Event ID 71124
510(K)Number K060937  
Product Classification System, x-ray, tomography, computed - Product Code JAK
Product Computed Tomography X-ray systems Brilliance iCT, Philips Healthcare 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 Brilliance iCT: Model #728306; Serial #s: 85012, 85013, 85014, 100029, 100038, 100040, 100053, 100058, 100094, 100099, 100133, 100140, 100162, 100178, 100236, 100244, 100373, 100399, 100408, 100411, 100416, 100441, 100450, 100454, 100461, 100463, 100465, 100466, 100498, 100503, 100506, 100507, 100508, 100509, 100511, 100512, 100517 & 100518.
Recalling Firm/
Philips Medical Systems (Cleveland) Inc
595 Miner Rd
Cleveland OH 44143-2131
For Additional Information Contact Mr. Yuchol Kim
Manufacturer Reason
for Recall
5 issues. Fast Get Ready incorrectly enabled during service procedures. Contrast annotation missing for some images when manual contrast was administered. Dot artifact present, intermittently, after startup. Heart Rate measured value incorrectly remains constant for some heart rate change conditions. DoseRight incorrectly enabled when the Exam Card specified disabling DoseRight. Tube heat predict
FDA Determined
Cause 2
Software change control
Action On 2/5/2015 the firm sent Customer Information Letters to their customers.
Quantity in Commerce 38 units
Distribution Worldwide Distribution-US (nationwide) including the states of AR, AZ, CA, CT, DE, FL, GA, IA, IN, KS, LA, MA, MD, MI, MN, MO, MS, MT, NH, NJ, NM, NV, NY, OH, OR, PA, SC, TN, TX, UT, VT, WV & WY, and to the following countries: Argentina, Australia, Austria, Belgium, Bolivia, Brazil, Cambodia, Canada, China, Colombia, Denmark, Finland, France, Germany, Hong Kong, India, Indonesia, Iran, Iraq, Ireland, Italy, Japan, Latvia, Libyan Arab Jamahiriya, Lithuania, Malaysia, Mexico, Myanmar, Netherlands, New Zealand, Norway, Panama, Philippines, Russia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uzbekistan & Viet Nam.
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.