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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = JAK
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