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U.S. Department of Health and Human Services

Class 2 Device Recall Ingenuity Computed Tomography Xray Systems

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  Class 2 Device Recall Ingenuity Computed Tomography Xray Systems see related information
Date Initiated by Firm April 08, 2016
Create Date May 31, 2016
Recall Status1 Terminated 3 on July 02, 2018
Recall Number Z-1875-2016
Recall Event ID 73961
510(K)Number K033326  
Product Classification System, x-ray, tomography, computed - Product Code JAK
Product Ingenuity Computed Tomography X-ray Systems

Product Usage:
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 No. 728326; S/N: 300142 30003 30005 30006 30007 30008 30009 30010 30011 30012 30013 30014 30015 30017 30018 30019 30020 30021 30022 30025 30026 30027 30028 30029 30030 30031 30032 30033 30034 30035 30036 30037 30038 30039 30040 30041 30042 30043 30044 30045 30046 30049 32083 32107 52060 300003 300004 300005 300010 300011 300012 300013 300014 300015 300016 300017 300018 300019 300020 300021 300022 300024 300025 300027 300028 300029 300030 300031 300032 300033 300034 300035 300036 300037 300038 300039 300040 300041 300042 300043 300044 300045 300047 300049 300050 300051 300052 300053 300054 300055 300056 300057 300058 300059 300060 300061 300062 300063 300064 300065 300066 300068 300069 300070 300071 300072 300073 300074 300075 300077 300078 300079 300080 300081 300082 300083 300084 300086 300087 300088 300089 300090 300091 300092 300093 300094 300095 300096 300097 300098 300099 300100 300101 300102 300103 300104 300105 300106 300107 300108 300109 300110 300111 300112 300113 300114 300115 300116 300117 300118 300119 300120 300121 300122 300123 300124 300125 300126 300127 300128 300129 300130 300131 300132 300133 300135 300136 300137 300138 300139 300140 300141 300143 300144 300145 300146 300147 300148 300149 300150 300151 300156 300157 300158 300159 300160 300161 300162 300163 300164 300165 300166 300200 300201 300202 300203 300204 300205 300206 300207 300208 300209 300210 300211 300212 310058 310144 320003 320205 333057 336061 336084 336121 941091 30004-1
Recalling Firm/
Manufacturer		 Philips Medical Systems (Cleveland) Inc
595 Miner Rd
Cleveland OH 44143-2131
For Additional Information Contact Mrs. Holly W. Lee
440-483-2997
Manufacturer Reason
for Recall		 The firm became aware of a problem where the system may not map Varian drive after CT user logout/login.
FDA Determined
Cause 2		 Software design
Action The firm sent a Customer Information letters dated March 8, 2016 to their customers. The letter identified the affected product, problem and actions to be taken. For information or support concerning this issue, please contact your local Philips representative or local Philips Healthcare office. For North America and Canada, contact the Customer Care Solutions Center (1-800-722-9377, Option 5: Enter Site ID or follow the prompts).
Quantity in Commerce 215 units
Distribution Worldwide Distribution - US Nationwide in the states of: 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, INC.
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