Class 2 Device Recall uMI 550 PET/CT System

• Date Initiated by Firm: August 05, 2020
• Create Date: November 12, 2020
• Recall Status: Open, Classified
• Recall Number: Z-0448-2021
• Recall Event ID: 86269
• 510(K)Number: K182237
• Product Classification: System, tomography, computed, emission - Product Code KPS
• Product: Positron Emission Tomography and Computed Tomography System, Model uMI 550, Rx, CE, GTIN: 06971576832026 - Product Usage: intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, restaging, treatment planning and treatment response evaluation for diseases and disorders in, but not limit to, oncology, cardiology and neurology.
• Code Information: Serial Numbers: 200017, 200023, 200024, 200036, 200045, 200047, 230002, 230003, 230004
• Recalling Firm/ Manufacturer: Shanghai United Imaging Healthcare Co., Ltd.; No. 2258 Chengbei Rd, Jiading Ind.; Shanghai China
• Manufacturer Reason for Recall: A potential issue of an incorrect CT scan delay timer to be displayed on the gantry Digital Display Panel (DDP) during multi-phase contrast scanning. This could lead the operator to receive unnecessary exposure to radiation.
• FDA Determined Cause: Software design
• Action: The firm sent notification letters via email to distributorsThe firm's consignee hand delivered a written Field Safety Notification to end-users on June 11, 2020 to inform them that the delay time displayed on the DDP can be incorrect for a timed scan such as a multi-phase contrast scan. The DDP is located on the gantry in the scan room. If the operator enters the scan room to perform any multi-phase contrast scan and refers to the incorrect delay time displayed on the DDP, he or she may not be able to leave the scan room before the scan starts, and as a result may receive unnecessary radiation dose. The letter states the following: The purpose of this letter is to advise you that United Imaging is voluntarily correcting some of the uCT 530, uCT 550, uCT 760 The uCT 530 and uMI 550 devices. Reason for the Voluntary Correction: We are aware of one complaint associated with the device. We have not received any report that have resulted in injury. Safety Issue: A potential issue of an incorrect CT scan delay timer to be displayed on the gantry Digital Display Panel (DDP) during multi-phase contrast scanning. Risk to Health of Safety Issue: The delay time displayed on the DDP can be incorrect for a timed scan such as a multi-phase contrast scan. The DDP is located on the gantry in the scan room. If the operator enters the scan room to perform any multi-phase contrast scan and refers to the incorrect delay time displayed on the DDP, he or she may not be able to leave the scan room before the scan starts, and as a result may receive unnecessary radiation dose. Actions to be taken by the Customer I User: 1. During a multi-phase contrast scan, do not perform any operations on the Preview image of any previous phases. 2. If possible, avoid entering the scan room when performing multi-phase contrast scans. 3. If it is necessary to enter the scan room when performing a multi-phase contrast scan, ignore the potentially incorrect delay time displayed on the
• Quantity in Commerce: 9
• Distribution: US Nationwide distribution including in the state of TX.
• 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 = KPS and Original Applicant = Shanghai United Imaging Healthcare Co., Ltd.