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U.S. Department of Health and Human Services

Class 2 Device Recall Head Holder shipped with Ingenuity Core 128 Computed Tomography Xray Systems

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  Class 2 Device Recall Head Holder shipped with Ingenuity Core 128 Computed Tomography Xray Systems see related information
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
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
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
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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