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U.S. Department of Health and Human Services

Class 2 Device Recall Philips Healthcare Ingenuity Core 128

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  Class 2 Device Recall Philips Healthcare Ingenuity Core 128 see related information
Date Initiated by Firm November 10, 2017
Create Date January 19, 2018
Recall Status1 Terminated 3 on November 05, 2020
Recall Number Z-0391-2018
Recall Event ID 78852
510(K)Number K160743  
Product Classification System, x-ray, tomography, computed - Product Code JAK
Product Ingenuity Core 128, (Code 728323)

Intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at different angles and planes.
Code Information Code 728323, SN # 320394, UDI: (01)00884838059474(21)320394; 320395, UDI: (01)00884838059474(21)320395; and 336286. 
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		 Philips has identified that certain fasteners cannot be confirmed to have been torqued according to specification. If the fasteners were not torqued as specified and a failure occurs while the system is in use, the parts secured by the fasteners may become loose, which may have a potential for harm.
FDA Determined
Cause 2		 Under Investigation by firm
Action An Urgent - Field Safety Notice Medical Device Correction letter, dated November 1, 2017, was sent to customers. The letter identified the affected device, described the issue, and discussed the hazard involved. Users are to cease use immediately and contact their Philips Field Service Engineer, if any unusual noises are heard within the gantry, or if the patient support tabletop is in free float. Philips Field Service Engineers will correct the system by replacing the affected fasteners. If further info or support concerning this issue is needed, customers can contact their local Philips rep or the Customer Care Solutions Center at 1-800-722-9377.
Quantity in Commerce 3
Distribution Worldwide Distribution -- US, Argentina, China, Republic of Korea, Russian Federation, Slovakia, Turkey, and United Kingdom. 4 in US, (1 military), 14 foreign 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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