Shanghai United Imaging Healthcare Co., Ltd. No. 2258 Chengbei Rd, Jiading Ind. Shanghai China 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Shanghai United Imaging Healthcare Co., Ltd. No. 2258 Chengbei Rd, Jiading Ind. Shanghai China
Lot Codes / Batch Numbers
Serial Number: 270012, 270013, 270014, 270015, 270016, 270017
Products Sold
Serial Number: 270012, 270013, 270014, 270015, 270016, 270017
Shanghai United Imaging Healthcare Co., Ltd. No. 2258 Chengbei Rd, Jiading Ind. Shanghai China is recalling Digitial Medica X-ray Imagining System, Model: uDR 596i, RX, CE0123, UDI:(01) 06971576833023 - Produ due to 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 pa. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026