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U.S. Department of Health and Human Services

Class 2 Device Recall Ingenuity Flex

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  Class 2 Device Recall Ingenuity Flex see related information
Date Initiated by Firm June 21, 2016
Create Date June 30, 2016
Recall Status1 Terminated 3 on July 02, 2018
Recall Number Z-2113-2016
Recall Event ID 74511
510(K)Number K033326  
Product Classification System, x-ray, tomography, computed - Product Code JAK
Product Ingenuity Flex, model # 728317; Intended to produce cross- sectional images of the body.
Code Information 901475, 901476, 901495, 901505, 901509, 901513, 901529, 901532, 901539, 901541
Recalling Firm/
Philips Medical Systems (Cleveland) Inc
595 Miner Rd
Cleveland OH 44143-2131
For Additional Information Contact Holly Wright Lee
Manufacturer Reason
for Recall
Supplier design change contributed to a thinner plastic which was used as part of the cover on the devices. The thinner plastic cover may crack causing injury to patients, operators, by-standers and service personnel.
FDA Determined
Cause 2
Nonconforming Material/Component
Action Philips is informing the consignee of this issue through: Customer Information Letter (CIL) 72800656 . International consignees will be contacted by Philips Healthcare Global Market representatives, who will distribute the CIL. A Field Service Engineer (FSE) will contact the customers to schedule a time to conduct the appropriate correction through Field Change Order (FCO) 72800656 once it is available. This FCO will address the above identified issue. A response form sent to the customer via certified mail. This package will also contain a return receipt.
Quantity in Commerce 10 units
Distribution Distributed in China, Denmark, Germany, Hungary, Italy, Philippines, Spain, Sweden, Switzerland, Thailand, and United Kingdom.
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, INC.