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U.S. Department of Health and Human Services

Class 2 Device Recall Brillance, Big Bore CT

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  Class 2 Device Recall Brillance, Big Bore CT see related information
Date Initiated by Firm April 25, 2006
Date Posted December 10, 2015
Recall Status1 Terminated 3 on December 15, 2015
Recall Number Z-0400-2016
Recall Event ID 69121
510(K)Number K033357  
Product Classification System, x-ray, tomography, computed - Product Code JAK
Product Brilliance CT (computed tomography) scanners, Big Bore configuration, Model number 728243. software version 2.0 The products are intended to provide cross sectional images of the human body and visualization of the internal organs of the body.
Code Information Model # 728243 Software Version 2.0
Recalling Firm/
Manufacturer		 Philips Medical Systems (Cleveland) Inc
595 Miner Rd
Cleveland OH 44143-2131
For Additional Information Contact Mrs. Holly Wright Lee
440-483-5777
Manufacturer Reason
for Recall		 Brilliance Big Bore- An anomaly was identified with software version 2.0 tumor localization application when printing work sheets. this causes information regarding relative locations of marked regions of interest on the patient work sheets to be incorrect and may cause mistreatment.
FDA Determined
Cause 2		 Software design
Action Philips Medical Systems sent a product safety notice to customers and corrective software for the issue was released to the field on July 25, 2006. Service Reps will contact each customer to install the new version of software. For questions regarding this recall call 440-483-7600.
Quantity in Commerce 54 units
Distribution Worldwide distribution, including US states of CA and NV.
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(CLEVELAND), INC.
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