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U.S. Department of Health and Human Services

Class 2 Device Recall Philips Healthcare Brilliance iCT

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  Class 2 Device Recall Philips Healthcare Brilliance iCT see related information
Date Initiated by Firm November 08, 2017
Create Date January 11, 2018
Recall Status1 Terminated 3 on April 17, 2020
Recall Number Z-0331-2018
Recall Event ID 78879
510(K)Number K060937  
Product Classification System, x-ray, tomography, computed - Product Code JAK
Product Philips Healthcare Brilliance iCT computed tomography x-ray system
Code Information Brilliance iCT - 728306 Devices manufactured 03/05/2009 to present. 
Recalling Firm/
Manufacturer		 Philips Medical Systems (Cleveland) Inc
595 Miner Rd
Cleveland OH 44143-2131
For Additional Information Contact Holly Wright Lee
440-483-7600
Manufacturer Reason
for Recall		 There is a possibility that screws holding an internal portion of the gantry (Reaction Ring) to the scanner s main bearing may come loose. If this occurs, the part(s) will not be expelled, however, a noise may be heard coming from the gantry.
FDA Determined
Cause 2		 Device Design
Action Philips Healthcare is informing consignees of this issue through a Customer Information Letter (CIL_FCO72800690). Philips Key Market representatives will distribute the letter internationally, based on local regulations. Additionally, a Field Service Engineer will contact each site to schedule a time to implement the Field Change Order. Customers are notified that if they hear an unusual noise coming from the gantry, or scan halts, the Philips representative should be contacted as soon as possible. Philips will be inspecting the affected systems, tightening and replacing the reaction ring screws as needed at no additional cost.
Quantity in Commerce 702
Distribution 107 domestic accounts 15 US Govt accounts 682 Foreign Accounts 3 Mexico accounts 12 Canada accounts
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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