Class 2 Device Recall Computed Tomography XRay System

• Date Initiated by Firm: June 20, 2020
• Create Date: July 27, 2020
• Recall Status: Open, Classified
• Recall Number: Z-2705-2020
• Recall Event ID: 85868
• 510(K)Number: K181414
• Product Classification: System, x-ray, tomography, computed - Product Code JAK
• Product: Computed 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: 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: 2
• 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