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Class 2 Device Recall Brillance CT System |
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Date Initiated by Firm |
December 27, 2005 |
Date Posted |
September 26, 2014 |
Recall Status1 |
Terminated 3 on November 06, 2015 |
Recall Number |
Z-2709-2014 |
Recall Event ID |
69123 |
510(K)Number |
K033326 K010817
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Product Classification |
System, x-ray, tomography, computed - Product Code JAK
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Product |
Brilliance CT System 6/10/16/16P/40 configuration. No packaging, sold as single unit.
Computed tomography scanner intended to provide cross sectional images of the human body and visualization of the internal organs. |
Code Information |
728256, 728251, 728246, 728240, and 728235. |
Recalling Firm/ Manufacturer |
Philips Medical Systems (Cleveland) Inc 595 Miner Rd Cleveland OH 44143-2131
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For Additional Information Contact |
440-483-7600
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Manufacturer Reason for Recall |
The system has a gap that can appear between the upper and lower tilt stand covers. The fingers may be squeezed if a person was to place them in this region while the gantry was tilting from an angle to zero tilt angle.
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FDA Determined Cause 2 |
Device Design |
Action |
Customers will be contacted by a field service technician with the field correction order. The firm will install the new labeling to the device. |
Quantity in Commerce |
364 |
Distribution |
Worldwide Distribution -- AZ, CO, GA, IA, IL, IN, KS, KY, MD, MI, MN, MS, NC, NY, OH, OK, TX, VT, and WI; and, countries of Singapore, New Zealand, India, Australia, Korea, Japan, Korea, China, India, Taiwan, Australia, Turkey, France, South Africa, Spain, Italy, Austria, Belgium, Switzerland, Israel, Netherlands, England, and Brazil. |
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(CLEVELAND), INC. 510(K)s with Product Code = JAK and Original Applicant = PHILIPS MEDICAL SYSTEMS, INC.
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