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Class 2 Device Recall Head Holder shipped with Ingenuity Core Computed Tomography Xray Systems |
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Date Initiated by Firm |
March 17, 2015 |
Date Posted |
July 22, 2015 |
Recall Status1 |
Terminated 3 on June 26, 2018 |
Recall Number |
Z-2203-2015 |
Recall Event ID |
71227 |
510(K)Number |
K033326
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Product Classification |
System, x-ray, tomography, computed - Product Code JAK
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Product |
Head 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. |
Recalling Firm/ Manufacturer |
Philips Medical Systems (Cleveland) Inc 595 Miner Rd Cleveland OH 44143-2131
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For Additional Information Contact |
Mr. Yuchol Kim 440-483-2997
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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.
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FDA Determined Cause 2 |
Mixed-up of materials/components |
Action |
On 6/4/2015, the firm mailed Customer Information Letters. |
Quantity in Commerce |
79 units |
Distribution |
Worldwide 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 Cycle |
TPLC Device Report
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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.
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510(K) Database |
510(K)s with Product Code = JAK and Original Applicant = PHILIPS MEDICAL SYSTEMS, INC.
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