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.
Check against the official notice below — it lists the full affected range.
Shanghai United Imaging Healthcare Co., Ltd. has recalled six units of its uDR 596i Digital Medical X-Ray Imaging System due to two software-related issues. The first issue involves incorrect anatomical position illustrations in the patient exam interface, which can result in images acquired with wrong reference positions that do not meet clinical diagnostic requirements. The second issue occurs when image stitching is used, causing left and right tag information to be lost, which requires additional x-ray exposure to obtain proper images and exposes patients to unnecessary radiation.
The recalled units were distributed nationwide in the United States, including Texas. The affected systems are Model Number uDR 596i with specific software versions (R002.19.0-1.8402-690106 and R002.19.0.8648.690112) and serial numbers 270012 through 270017. The source document does not specify what remedy or corrective action affected consumers should take.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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. Distribution: US Nationwide distribution including in the state of Texas. Quantity: 6 units Lot/code info: 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.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.