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Class 2 Device Recall Ingenuity Flex |
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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
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Product Classification |
System, x-ray, tomography, computed - Product Code JAK
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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/ Manufacturer |
Philips Medical Systems (Cleveland) Inc 595 Miner Rd Cleveland OH 44143-2131
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For Additional Information Contact |
Holly Wright Lee 440-483-2015
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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.
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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
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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 and Original Applicant = PHILIPS MEDICAL SYSTEMS, INC.
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