• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 3 Device Recall Brilliance 16 Slice (Air)

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 3 Recall
Brilliance 16 Slice (Air)
see related information
Date Posted September 19, 2012
Recall Status1 Terminated on December 24, 2013
Recall Number Z-2404-2012
Recall Event ID 63006
Premarket Notification
510(K) Number
K012009 
Product Classification System, X-Ray, Tomography, Computed - Product Code JAK
Product The Brilliance CT 16 System Product Usage: The Brilliance 16 is a Whole Body Computed Tomography X-ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles.
Code Information System Code #, 728246, Serial #, 6462, 6447, 6495, 6514, 6467, 6482, 6473, 6544, 6439, 6453, 6436, 6536, 6448, 6449, 6471, 6498, 6502, 6504, 6452, 6510, 6508, 6438, 6513, 6456, 6505, 6457, 6442, 6454, 6461, 6469, 6485, 6458, 6475, 6487, 6531, 6520, 6490, 6470, 6437, 6497, 6481, 6489, 6488, 6455, 6543, 6499, 6493, 6443, 6463, 6476, 6477, 6478, 6526, 6545, 6546, 6518, 6491, 6450, 6451, 6468, 6464, 6466, 6459, 6472, 6444, 6445, 6529, 6530, 6440, 6532, 6515, 6486, 6507, 6512, 6483, 6524, 6480, 6479, 6509, 6460, 6441, 6465, 6474, 6484, 6492, 6503, 6511, 6517, 6519, 6523, 6525, 6549, 6555
Recalling Firm/
Manufacturer
Philips Medical Systems (Cleveland) Inc
595 Miner Road
Cleveland, Ohio 44143-2131
For Additional Information Contact Kumudini J. Carter
440-483-7000
Manufacturer Reason
for Recall
Philips was notified that the system logout in software version 2.3.6 is now longer and may sometimes fail to logout, requiring a forced system restart or hard shutdown with the power button.
FDA Determined
Cause 2
CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Software Change Control
Action Philips sent an Urgent - Medical Device Correction letter dated August 24, 2012 via certified mail to all US consignees. Philips Key Market representatives distributed the letter internationally. The letter identified the affected product, problem and actions to be taken by customer/user. Philips is implementing a software update to correct the issue free of charge. A Philips representative will contact affect sites to schedule the software installation. For further information or support contact your Philips representative or local Philips Healthcare office.
Quantity in Commerce 93 units
Distribution Worldwide Distribution - US Nationwide including the states of: AL, CA, GA, MA, MD, NC, OH, PA, TX, and WA; and to the following countries of: Algeria, Oman, Australia, Brazil, China, Saudi Arabia, United Arab Emirates, and India.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = JAK and Original Applicant = MARCONI MEDICAL SYSTEMS, INC.
-
-