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U.S. Department of Health and Human Services

Class 2 Device Recall Computed Tomography XRay System

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 Class 2 Device Recall Computed Tomography XRay Systemsee related information
Date Initiated by FirmJune 20, 2020
Create DateJuly 27, 2020
Recall Status1 Open3, Classified
Recall NumberZ-2705-2020
Recall Event ID 85868
510(K)NumberK181414 
Product Classification System, x-ray, tomography, computed - Product Code JAK
ProductComputed Tomography X-ray System; Model uCT 550; Rx; UDI: (01) GTIN: 06971576831036 - 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 353020, 353021
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
ActionA 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 Commerce2
DistributionUS Nationwide distribution including in the states of CA, IN and TX. See uploaded distribution list for more details.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = JAK
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