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U.S. Department of Health and Human Services

Class 2 Device Recall Ingenuity Core Computed Tomography Xray systems

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  Class 2 Device Recall Ingenuity Core Computed Tomography Xray systems see related information
Date Initiated by Firm March 24, 2016
Create Date August 09, 2016
Recall Status1 Terminated 3 on July 02, 2018
Recall Number Z-2371-2016
Recall Event ID 73750
510(K)Number K033326  
Product Classification System, x-ray, tomography, computed - Product Code JAK
Product Ingenuity Core Computed Tomography X-ray systems is 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 #: 728321; Serial #s: 310004, 310005, 310012, 310016, 310020, 310021, 310027, 310028, 310033, 310034, 310041, 310044, 310045, 310057, 310061, 310065, 310072, 310074, 310076, 310077, 310078, 310094, 310099, 310100, 310103, 310105, 310117, 310120, 310135.
Recalling Firm/
Philips Medical Systems (Cleveland) Inc
595 Miner Rd
Cleveland OH 44143-2131
For Additional Information Contact Holly Wright Lee
Manufacturer Reason
for Recall
Software defect causing intermittently slow response of Host.
FDA Determined
Cause 2
Software change control
Action On 3/24/2016 the firm mailed Customer Information letters to their customers.
Quantity in Commerce 29 units
Distribution Product was sent to the following states: AK, AL, AR, AZ, CA, CO, CT, DC, 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 sent to the following countries: Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Cambodia, Canada, China, Colombia, Cuba, Denmark, Djibouti, Egypt, Estonia, Finland, France, Germany, Ghana, Gibraltar, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Martinique, Mexico, Monaco, Mongolia, Mozambique, Myanmar, Netherlands, New Zealand, Norway, Oman, Palestine, Panama, Philippines, Poland, Portugal, R¿union, Russian Federation, Senegal, Singapore, Slovakia, South Africa, 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, INC.