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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 December 23, 2016
Create Date January 20, 2017
Recall Status1 Terminated 3 on June 26, 2018
Recall Number Z-1058-2017
Recall Event ID 76144
510(K)Number K060937  
Product Classification System, x-ray, tomography, computed - Product Code JAK
Product Brilliance iCT
Code Information Rotor-4535-673-94382 SN 19, installed on Brilliance ICT System S/N 200203
Recalling Firm/
Manufacturer		 Philips Medical Systems (Cleveland) Inc
595 Miner Rd
Cleveland OH 44143-2131
For Additional Information Contact Ms. Holly Wright Lee
440-483-5777
Manufacturer Reason
for Recall		 During a retrospective review of production documentation it was observed that the M6 Rotor Counterweight Bolt may have been improperly torqued.
FDA Determined
Cause 2		 Employee error
Action Philips sent an Customer Information letter. A document showed an incorrect torque wrench used during the assembly process which could potentially apply 4 Newton-meters less torque than specified to the system rotor counterweight bolts. Out of an abundance of caution, Philips will have a Field Service Engineer ensure the bolts on your system are correctly torqued. If you need any further information or support concerning this issue, please contact your local Philips representative. For further information please call (440) 483-5777.
Quantity in Commerce 1-unit
Distribution Product was not distributed in the US. Unit was distributed in Australia.
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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