| Class 2 Device Recall Ingenuity Core 128 | |
Date Initiated by Firm | June 21, 2016 |
Create Date | June 30, 2016 |
Recall Status1 |
Terminated 3 on July 02, 2018 |
Recall Number | Z-2114-2016 |
Recall Event ID |
74511 |
510(K)Number | K033326 |
Product Classification |
System, x-ray, tomography, computed - Product Code JAK
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Product | Ingenuity Core 128, model #728323; Intended to produce cross- sectional images of the body. |
Code Information |
901469, 901479, 901487, 901491, 901497, 901502, 901508, 901515, 901517, 901518, 901520, 901530, 901533, 921223 |
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 |
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 | 14 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
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