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U.S. Department of Health and Human Services

Class 2 Device Recall Philips Ingenuity Core128/Elite China 728324

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  Class 2 Device Recall Philips Ingenuity Core128/Elite China 728324 see related information
Date Initiated by Firm March 28, 2018
Create Date June 22, 2018
Recall Status1 Terminated 3 on April 21, 2020
Recall Number Z-2277-2018
Recall Event ID 80176
510(K)Number K160743  
Product Classification System, x-ray, tomography, computed - Product Code JAK
Product Ingenuity Core128/Elite China 728324
Code Information UDI: (01)00884838059863(21)336856, Serial Number: 336856;  UDI: (01)00884838059863(21)336851, Serial Number: 336851;  UDI: (01)00884838059863(21)336849, Serial Number: 336849;  UDI: (01)00884838059863(21)336852, Serial Number: 336852; UDI: (01)00884838059863(21)336853, Serial Number: 336853;  UDI: (01)00884838059863(21)336855, Serial Number: 336855;  UDI: (01)00884838059863(21)336854, Serial Number: 336854;  UDI: (01)00884838059863(21)336850, Serial Number: 336850
Recalling Firm/
Manufacturer
Philips Medical Systems (Cleveland) Inc
595 Miner Rd
Cleveland OH 44143-2131
For Additional Information Contact Holly Wright Lee
440-483-5777
Manufacturer Reason
for Recall
A problem has been detected in the X-Ray Tube. The affected tubes have a production defect that allows oil leakage from the tube housing, if it were to re-occur, could pose a risk for patients or users.
FDA Determined
Cause 2
Other
Action Urgent Field Safety Notice letters were sent to customers on 3/28/18. The letters did not request any actions to be conducted by the customers. For Brilliance Big Bore/ Ingenuity CT / Ingenuity Core / Ingenuity Corel 28 Customers: A Philips Field Service Engineer will contact you to schedule the FCO updates at your site. Field Change Order (FCO 72800691 and 72800692) will be released to correct the issue. For Ingenuity TF PET/CT Customers: Field Change Order (FCO 88200520 and 88200511) will be released to correct this issue. A Philips Field Service Engineer will contact you to schedule the FCO updates at your site.
Distribution The systems were distributed to the following US states: HI, KS, and MO. The systems were distributed to the following foreign countries: Algeria, Austria, Brazil, China, Indonesia, Japan, Kenya, Korea, Mexico, Poland, Turkey, and Uganda.
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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