Date Initiated by Firm |
February 27, 2020 |
Create Date |
July 08, 2020 |
Recall Status1 |
Terminated 3 on May 28, 2021 |
Recall Number |
Z-2521-2020 |
Recall Event ID |
85196 |
510(K)Number |
K181413
|
Product Classification |
System, x-ray, stationary - Product Code KPR
|
Product |
uDR 596i Digital Medical X-Ray Imaging System - Product Usage: intended to use 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. |
Code Information |
Model Number uDR 596i with software versions R002.19.0-1.8402-690106 and R002.19.0.8648.690112. Serial numbers: 270012, 270013, 270014, 270015, 270016 and 270017. UDI numbers: (01)06971576833023(240)88000093(21)270012; (01)06971576833023(240)88000093(21)270013; (01)06971576833023(240)88000093(21)270014; (01)06971576833023(240)88000093(21)270015; XXX; and XXX. |
Recalling Firm/ Manufacturer |
Shanghai United Imaging Healthcare Co., Ltd. No. 2258 Chengbei Rd, Jiading Ind. Shanghai China
|
Manufacturer Reason for Recall |
Two issues were identified with the stationary x-ray system. 1. Some position illustrations in the patient exam interface show the incorrect anatomical position for the standard of care. When the image is acquired with the wrong reference position, clinical diagnostic requirements cannot be met.T2. Where image stitching is used, the left and right tag information may be lost. When these problems are encountered, an additional exposure is needed and the patient will receive more radiation.
|
FDA Determined Cause 2 |
Software design |
Action |
The firm sent a Customer Notification Letter by email on February 27, 2020. The letter included identification of the serial numbers of devices affected by this issue. The firm's direct customers were instructed to identify users of the affected systems which have been installed. Customers were informed that they should not refer to illustrations showing the incorrect anatomical position for the standard of care, and that the impacted systems will be immediately remedied with a software hotfix on R002.19.0-4.8648-690113 software version via field software update.
Customers with questions were instructed to call (855) 221-1552 (toll free) or (832) 699-2799 (direct). |
Quantity in Commerce |
6 units |
Distribution |
US Nationwide distribution including in the state of Texas. |
Total Product Life Cycle |
TPLC Device Report
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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.
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510(K) Database |
510(K)s with Product Code = KPR and Original Applicant = Shanghai United Imaging Healthcare Co.,Ltd.
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