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U.S. Department of Health and Human Services

Class 2 Device Recall Brilliance iCT SP

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  Class 2 Device Recall Brilliance iCT SP see related information
Date Initiated by Firm April 29, 2016
Create Date August 10, 2016
Recall Status1 Terminated 3 on July 02, 2018
Recall Number Z-2382-2016
Recall Event ID 74131
510(K)Number K060937  
Product Classification System, x-ray, tomography, computed - Product Code JAK
Product Brilliance iCT SP Model No. 728311; To produce cross-sectional images of the body.
Code Information Brilliance iCT SP Model No. 728311  S/N:200107,200003,200011,200009,200017,200074,200022,200013,200027,200049,200032, 200030,200043,200040,200038,200047,200051,200044,200063,200061,200068,200067, 200089,200088,200092,200093,200101,200097,200100,200105,200109,200121,200204, 200111,200117,200127,200131,200200,200205,200138,200202,200201,200203,200209, 200210,200206,200208,200207,200211,200019,200015,200029,200024,200023,200025, 200026,200041,200086,200102,200213  
Recalling Firm/
Manufacturer		 Philips Medical Systems (Cleveland) Inc
595 Miner Rd
Cleveland OH 44143-2131
For Additional Information Contact Mrs. Holly Lee
440-483-2015
Manufacturer Reason
for Recall		 Software issues found in v4.1 .3/4.1.5 in the Philips Brilliance iCT/ iCT SP products that could affect the performance of the equipment.
FDA Determined
Cause 2		 Software design
Action The customers will be sent a letter with information about, what the problems are and under what circumstances they may occur, the actions customers can take to minimize the effect of the problem and the actions planned by Philips to correct the problem. To correct these issues, a Philips field service representative will install a software update on the affected systems. Reference field change order (FCO) 72800652.
Quantity in Commerce 57 Units
Distribution Product was shipped to the following states: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WV & WY. Product was also shipped to the following countries: Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Cambodia, China, Colombia, Cuba, Estonia, Finland, France, Germany, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Latvia, Lebanon, Libya, Lithuania, Malaysia, Myanmar, Netherlands, New Zealand, Norway, Palestine, Panama, Philippines, Poland, Portugal, R¿union, Russian Federation, Senegal, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Turkey, United Arab Emirates, United Kingdom, Uzbekistan & Vietnam.
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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