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U.S. Department of Health and Human Services

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

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  Class 2 Device Recall Head Holder shipped with Ingenuity CT 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-2205-2015
Recall Event ID 71227
510(K)Number K033326  
Product Classification System, x-ray, tomography, computed - Product Code JAK
Product Head Holder shipped with Ingenuity CT Computed Tomography X-ray Systems
Code Information Head Holder M/N 4535 671 11331. Ingenuity CT M/N 728326, Serial #s: 6617, 10607, 10689, 32000, 300043, 300064, 300068, 300071, 300072, 300073, 300074, 300075, 300076, 300077, 300078, 300079, 300080, 300081, 300082, 300084, 300085, 300086, 300087, 300088, 300089, 300091, 300092, 300093, 300094, 300095, 300096, 300097, 300098, 300099, 300100, 300101, 300102, 300103, 300104, 300105, 300106, 300107, 300108, 300109, 300110, 300111, 300112, 300113, 300114, 300116, 300117, 300118, 300119, 300120, 300121, 300122, 300123, 300124, 300125, 300126, 300127, 300128, 300129, 300130, 300131 & 300132.
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 CT, 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 66 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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