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U.S. Department of Health and Human Services

Class 2 Device Recall Philips Healthcare Brilliance CT 64

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  Class 2 Device Recall Philips Healthcare Brilliance CT 64 see related information
Date Initiated by Firm July 20, 2016
Create Date August 25, 2016
Recall Status1 Terminated 3 on July 02, 2018
Recall Number Z-2652-2016
Recall Event ID 74820
510(K)Number K033326  
Product Classification System, x-ray, tomography, computed - Product Code JAK
Product Brilliance 64 CT Model number 728231

Product Usage:
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 9033 9037 9043 9045 9064 9065 9070 9075 9086 9089 9104 9108 9120 9151 9156 9172 9190 9243 9259 9507 9508 9511 9526 9530 9531 9534 9547 9564 9580 9584 9598 9603 9606 9608 9613 9614 9630 9642 9655 9672 9695 9697 9690 9706 9713 9732 9735 9736 9757 9759 9812 9830 9835 9866 9875 9881 9889 9918 9936 9937 9951 9965 9968 9969 9975 9978 9992 9999 10036 10041 10046 10054 10067 10070 10080 10095 10103 10125 10141 10256 10292 10359 10363 10372 10380 10381 10386 10426 10473 10486 10505 10513 10527 10535 10561 10570 10645 10651 10655 10673 10686 10733 10743 10773 10776 29007 29016 29018 29025 29027 29037 29053 29097 90031 90047 90063 90128 95003 95058 95068 95210 95357 95811 29054 9107 9666 9700 29038 9858 9009 9029 9038 9051 9058 9067 9068 9072 9073 9092 9105 9106 9502 9503 9512 9516 9522 9525 9533 9545 9550 9551 9556 9572 9577 9591 9594 9596 9612 9618 9620 9624 9625 9626 9628 9633 9634 9635 9639 9641 9648 9650 9663 9676 9678 9685 9691 9692 9694 9705 9716 9726 9729 9740 9750 9751 9752 9753 9754 9775 9777 9780 9788 9790 9793 9809 9811 9821 9823 9826 9843 9846 9855 9857 9861 9869 9873 9878 9879 9882 9885 9894 9895 9902 9906 9917 9924 9938 9942 9948 9954 9960 9961 9966 9974 9982 9985 9994 10001 10014 10035 10037 10045 10065 10079 10085 10086 10096 10098 10111 10112 10113 10120 10148 10190 10200 10202 10224 10263 10291 10310 10332 10353 10365 10370 10371 10388 10413 10417 10424 29005 29035 29068 64015 90062 95008 95057 95348 9851T 10122 10373 10211 9139 10005 10026 10030 10031 10194 95149 95377 95392 9980 9698 9787  
Recalling Firm/
Manufacturer		 Philips Medical Systems (Cleveland) Inc
595 Miner Rd
Cleveland OH 44143-2131
For Additional Information Contact Mrs. Holly Wright Lee
440-483-2015
Manufacturer Reason
for Recall		 After upgrading to 3.6.7 software version via FCO72800643, during reconstruction of gated helical scans, the planned anatomy can be cut off on the CT images. This issue can occur on gated CT helical reconstruction that is not planned at iso-center (0,0). If the region of interest is not visualized in the images, a CT rescan may be performed.
FDA Determined
Cause 2		 Software Design Change
Action Customers were sent a letter dated July 28, 2016 informing them of the problem, under what circumstances it can occur and the actions that the customer can take to minimize the effect of the problem. The letter also includes the actions planned by Philips to correct the problem. Philips plans on releasing a field change order (FCO) to correct the affected systems. If you need any further information or support concerning this issue, contact your local Philips representative or local Philips Healthcare office. For North America and Canada, contact the Customer Care Solutions Center (1 -800-722-9377).
Quantity in Commerce 283
Distribution US Nationwide Distribution in the states of: AL,AR,AZ,CA,CO,CT,DC,DE,FL,GA,HI,IA,ID,IL,IN,KS,KY,LA,MA, MD,ME,MI,MN,MO,MS,NC,ND,NE,NJ,NM, NV,NY,OH,OK,OR,PA,PR,SC,TN,TX,UT,VA,VT,WA,WI,WV,WY
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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