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U.S. Department of Health and Human Services

Class 2 Device Recall Stationary xray system

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  Class 2 Device Recall Stationary xray system see related information
Date Initiated by Firm January 25, 2021
Create Date March 02, 2021
Recall Status1 Terminated 3 on May 03, 2022
Recall Number Z-1160-2021
Recall Event ID 87289
510(K)Number K181413  
Product Classification System, x-ray, stationary - Product Code KPR
Product Digitial Medica X-ray Imagining System, Model: uDR 596i, RX, CE0123, UDI:(01) 06971576833023 - Product Usage: intended to used by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, limbs and trunk. Not for mammography.
Code Information Serial Number: 270012, 270013, 270014, 270015, 270016, 270017
Recalling Firm/
Manufacturer		 Shanghai United Imaging Healthcare Co., Ltd.
No. 2258 Chengbei Rd, Jiading Ind.
Shanghai China
Manufacturer Reason
for Recall		 There is a potential for the X-Ray tube head (Touch screen interface) to perform an uncommanded motion. This could result in a collision with the patient.
FDA Determined
Cause 2		 Device Design
Action On 01/25/2021, Shanghai United Imaging sent an Urgent: Medical Device Correction via: Email. In addition to informing consignees about the recall, the firm asked customers to take the following actions: 1. Once the RHA motor driver is powered on, and while the RHA motor is looking for the zero-position (before its first electric movements), please do not apply any external force to the TUI. 2. For further questions, please contact your United Imaging Service Engineer or call the United Imaging Customer Contact Center at our 24-hour hotline (855) 221-1552 (toll free) or (832) 699-2799 (direct). 3. Adverse reactions or quality problems experienced with the use of this product may be reported to FDAs MedWatch Adverse Event Reporting program either online, by regulatory mail or by fax. 4. Notify all users of the affected products via this Customer Notification Letter. 5. Please completed the Receipt of Customer Notification Letter form and return to United Imaging.
Quantity in Commerce 6 units
Distribution US Nationwide distribution 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KPR and Original Applicant = Shanghai United Imaging Healthcare Co.,Ltd.
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