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U.S. Department of Health and Human Services

Class 2 Device Recall Brilliance CT 16 Power

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  Class 2 Device Recall Brilliance CT 16 Power see related information
Date Initiated by Firm March 16, 2015
Date Posted May 22, 2015
Recall Status1 Terminated 3 on February 22, 2017
Recall Number Z-1651-2015
Recall Event ID 71177
510(K)Number K012009  
Product Classification System, x-ray, tomography, computed - Product Code JAK
Product Brilliance CT 16 Power.

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 System Code #, 728240, Serial #, 60008.
Recalling Firm/
Manufacturer		 Philips Medical Systems (Cleveland) Inc
595 Miner Rd
Cleveland OH 44143-2131
For Additional Information Contact Mr. Yuchol Kim
440-483-2997
Manufacturer Reason
for Recall		 The firm was informed that while raising the patient couch on the system to perform an exam, the couch unexpectedly descended to the lowest point without being commanded to do so.
FDA Determined
Cause 2		 Employee error
Action On 3-18-2015 the firm sent Urgent Field Safety Notices to their customers.
Quantity in Commerce 153 units total
Distribution Distributed in China.
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 = MARCONI MEDICAL SYSTEMS, INC.
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