| Class 2 Device Recall Head Holder shipped with Ingenuity Core 128 Computed Tomography Xray Systems | |
Date Initiated by Firm | March 17, 2015 |
Date Posted | July 22, 2015 |
Recall Status1 |
Terminated 3 on June 26, 2018 |
Recall Number | Z-2204-2015 |
Recall Event ID |
71227 |
510(K)Number | K033326 |
Product Classification |
System, x-ray, tomography, computed - Product Code JAK
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Product | Head Holder shipped with Ingenuity Core 128 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 128 - M/N 728323, Serial #s: 300068, 320003, 320004, 320005, 320006, 320007, 320008, 320009, 320010, 320011, 320013, 320014, 320015, 320017, 320018, 320019, 320020, 320021, 320022, 320023, 320024, 320025, 320026, 320027, 320028, 320029, 320030, 320031, 320032, 320033, 320034, 320035, 320036, 320037, 320038, 320040, 320041, 320042, 320043, 320044, 320045, 320046, 320047, 320048, 320049, 320050, 320052, 320053, 320054, 320055, 320056, 320057, 320058, 320059 & EP16E110092. |
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 |
Manufacturer Reason for Recall | A head holder released for use with other CT systems but not yet qualified for use on the Ingenuity Core 128, which was shipped with this system. |
FDA Determined Cause 2 | Mixed-up of materials/components |
Action | On 6/4/2015, the firm mailed Customer Information Letters. |
Quantity in Commerce | 55 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
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