FDA Medical Device Recalls (openFDA)
Shanghai United Imaging Healthcare Co., Ltd.: 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 number
- Z-1160-2021
- Recalling firm
- Shanghai United Imaging Healthcare Co., Ltd.
- 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.
- Status
- Terminated
- Initiated
- 2021-01-25
- Posted
- not on file
- Terminated
- 2022-05-03
- Reason
- 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.
- Root cause
- 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
- 6 units
- Distribution
- US Nationwide distribution in the state of TX.
- Lot, serial or model codes
- Serial Number: 270012, 270013, 270014, 270015, 270016, 270017
- 510(k) numbers
- ["K181413"]
- PMA numbers
- not on file
- Product code
- KPR
- Firm FEI
- 3011015597
- Firm city
- Shanghai
- Firm state
- not on file
- Firm country
- China
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28