United Imaging Recalls uDR 596i Digital Medical X-Ray Imaging Systems
Shanghai United Imaging Healthcare is recalling six uDR 596i digital medical X-ray systems due to software errors that may cause incorrect anatomical positioning or loss of image tags, leading to additional radiation exposure.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (excess radiation exposure) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Shanghai United Imaging Healthcare Co., Ltd. is recalling six units of the uDR 596i Digital Medical X-Ray Imaging System. The affected units were distributed nationwide in the United States, including in Texas. The systems are intended for use by qualified doctors or technicians to take diagnostic radiographic exposures of various body parts on adult and pediatric subjects.
The recall was initiated due to two software issues. First, some position illustrations in the patient exam interface display the incorrect anatomical position for the standard of care, which may prevent clinical diagnostic requirements from being met. Second, when image stitching is used, left and right tag information may be lost. These errors may require additional exposures, resulting in patients receiving more radiation than necessary.
Healthcare facilities should contact Shanghai United Imaging Healthcare for instructions on how to resolve these issues. The recall covers specific serial numbers and software versions identified in the agency's records.
The recalled product
- 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…
- Manufacturer
- Shanghai United Imaging Healthcare Co., Ltd.
- Affected units
- 6
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (9)
- 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.
Distribution
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