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U.S. Department of Health and Human Services

Class 2 Device Recall UCT Computed Tomography XRay System

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  Class 2 Device Recall UCT Computed Tomography XRay System see related information
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  
Product Classification System, x-ray, tomography, computed - Product Code JAK
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
Manufacturer Reason
for Recall		 The metal edge overlap of the mylar strip in the gantry was uneven, which may create a sharp edge.
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
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.
510(K) Database 510(K)s with Product Code = JAK and Original Applicant = Shanghai United Imaging Healthcare Co., Ltd.
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