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U.S. Department of Health and Human Services

Class 2 Device Recall Brilliance CT Big Bore Oncology

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  Class 2 Device Recall Brilliance CT Big Bore Oncology see related information
Date Initiated by Firm June 21, 2016
Create Date June 30, 2016
Recall Status1 Terminated 3 on July 02, 2018
Recall Number Z-2111-2016
Recall Event ID 74511
510(K)Number K033357  
Product Classification System, x-ray, tomography, computed - Product Code JAK
Product Brilliance CT Big Bore Oncology, model #728243; Intended to produce cross- sectional images of the body.
Code Information 921216
Recalling Firm/
Manufacturer		 Philips Medical Systems (Cleveland) Inc
595 Miner Rd
Cleveland OH 44143-2131
For Additional Information Contact Holly Wright Lee
440-483-2015
Manufacturer Reason
for Recall		 Supplier design change contributed to a thinner plastic which was used as part of the cover on the devices. The thinner plastic cover may crack and cause injury to patients, operators, by standers or service personnel.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Philips is informing the consignee of this issue through: Customer Information Letter (CIL) 72800656 . International consignees will be contacted by Philips Healthcare Global Market representatives, who will distribute the CIL. A Field Service Engineer (FSE) will contact the customers to schedule a time to conduct the appropriate correction through Field Change Order (FCO) 72800656 once it is available. This FCO will address the above identified issue. A response form sent to the customer via certified mail. This package will also contain a return receipt.
Quantity in Commerce 3 units
Distribution Distributed in China, Denmark, Germany, Hungary, Italy, Philippines, Spain, Sweden, Switzerland, Thailand, and United Kingdom.
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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