| Class 2 Device Recall Philips Healthcare Brilliance BigBore Oncology CT |  |
Date Initiated by Firm | July 20, 2016 |
Create Date | August 25, 2016 |
Recall Status1 |
Terminated 3 on July 02, 2018 |
Recall Number | Z-2653-2016 |
Recall Event ID |
74820 |
510(K)Number | K033357 |
Product Classification |
System, x-ray, tomography, computed - Product Code JAK
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Product | Brilliance CT Big Bore Oncology, Model number 728243
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 |
728243 Brilliance BigBore Oncology CT 7116 7611 7354 7063 7309 7169 7205 7016 7019 7043 7069 7073 7091 7112 7132 7163 7141 7194 7226 7325 7294 7350 7316 7480 7114 7210 7310 7438 7530 7186 7119 7042 |
Recalling Firm/ Manufacturer |
Philips Medical Systems (Cleveland) Inc 595 Miner Rd Cleveland OH 44143-2131
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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 | 33 |
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 |
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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
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