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Class 2 Device Recall UCT Computed Tomography XRay System |
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Date Initiated by Firm |
June 20, 2020 |
Create Date |
July 27, 2020 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-2703-2020 |
Recall Event ID |
85868 |
510(K)Number |
K172135
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Product Classification |
System, x-ray, tomography, computed - Product Code JAK
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Product |
Computed Tomography X-ray System; Model uCT 760; Rx; UDI: (01) GTIN: 06971576831043 - Product Usage: intended to produce cross-sectional images of the body using computer reconstruction of x-ray transmission data taken at different angles and planes and indicated for the whole body (including head, neck, cardiac, and vascular). |
Code Information |
SN 600229, 600230, 600232, 600271, 600282 |
Recalling Firm/ Manufacturer |
Shanghai United Imaging Healthcare Co., Ltd. No. 2258 Chengbei Rd, Jiading Ind. Shanghai China
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Manufacturer Reason for Recall |
The metal edge overlap of the mylar strip in the gantry was uneven, which may create a sharp edge.
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FDA Determined Cause 2 |
Device Design |
Action |
A Customer Notification Letter was sent to the affected consignees on 06/20/2020 via email. United Imaging will replace the mylar strip with an improved one on the affected products via on-site update. |
Quantity in Commerce |
5 units |
Distribution |
US Nationwide distribution including in the states of CA, IN and TX. See uploaded distribution list for more details. |
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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510(K) Database |
510(K)s with Product Code = JAK and Original Applicant = Shanghai United Imaging Healthcare Co., Ltd.
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