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U.S. Department of Health and Human Services

Class 2 Device Recall Head Holder shipped with Ingenuity Core Computed Tomography Xray Systems

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 Class 2 Device Recall Head Holder shipped with Ingenuity Core Computed Tomography Xray Systemssee related information
Date Initiated by FirmMarch 17, 2015
Date PostedJuly 22, 2015
Recall Status1 Terminated 3 on June 26, 2018
Recall NumberZ-2203-2015
Recall Event ID 71227
510(K)NumberK033326 
Product Classification System, x-ray, tomography, computed - Product Code JAK
ProductHead Holder shipped with Ingenuity Core Computed Tomography X-ray Systems. 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 Head Holder M/N 4535 671 11331. Ingenuity Core - M/N 728321, Serial #s: 7725, 10614, 10663, 50171, 95735, 300072, 310001, 310006, 310008, 310009, 310010, 310012, 310013, 310014, 310015, 310017, 310018, 310020, 310021, 310022, 310024, 310025, 310026, 310028, 310029, 310030, 310031, 310032, 310033, 310034, 310035, 310037, 310038, 310039, 310040, 310041, 310042, 310043, 310044, 310045, 310046, 310047, 310048, 310049, 310050, 310051, 310052, 310053, 310054, 310055, 310056, 310057, 310058, 310059, 310060, 310061, 310062, 310063, 310064, 310065, 310066, 310067, 310068, 310069, 310070, 310071, 310072, 310073, 310074, 310075, 310076, 310077, 310078, 310079, 310080, 3100016, EP16E110078, EP16E120020 & EP16ER110018.
FEI Number 1525965
Recalling Firm/
Manufacturer		 Philips Medical Systems (Cleveland) Inc
595 Miner Rd
Cleveland OH 44143-2131
For Additional Information ContactMr. Yuchol Kim
440-483-2997
Manufacturer Reason
for Recall		A head holder released for use with other CT systems but not yet qualified for use on the Ingenuity Core, which was shipped with this system.
FDA Determined
Cause 2		Mixed-up of materials/components
ActionOn 6/4/2015, the firm mailed Customer Information Letters.
Quantity in Commerce79 units
DistributionWorldwide Distribution-Product was shipped to the following states: AR, AR, AZ, CA, CO, CT, FL, GA, IA, IN, KS, LA, MA, MD, MI, MO, MS, NC, NJ, NM, NV, NY, OH, OR, PA, SC, TN, TX, VA, VT, WA, WV & WY, and to the following countries: Argentina, Australia, Bangladesh, Belgium, Brazil, Bulgaria, China, Colombia, Denmark, Ecuador, France, Germany, India, Indonesia, Israel, Japan, Latvia, Libya, Myanmar, Norway, Oman, Poland, Republic of Korea, Russian Federation, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, United Kingdom & Viet Nam.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = JAK
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