United Imaging X-ray System Recalled for Uncommanded Motion Hazard
Shanghai United Imaging Healthcare is recalling six X-ray systems because the tube head may move unexpectedly, posing a collision risk to patients.
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 (potential collision with patient) 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 Digitial Medica X-ray Imagining System, Model uDR 596i, RX, CE0123. The recall involves specific serial numbers: 270012, 270013, 270014, 270015, 270016, and 270017. These devices were distributed in Texas.
The recall is due to a potential defect where the X-ray tube head (touch screen interface) may perform an uncommanded motion. This malfunction could result in a collision with the patient. The devices are intended for use by qualified doctors or technicians for diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, limbs, and trunk, but are not for mammography.
Healthcare facilities that have these specific serial numbers should contact the recalling firm for instructions on how to proceed. Patients who have used these devices should consult their healthcare provider if they have concerns regarding the recall.
The recalled product
- 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…
- 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 (6)
- Serial Number: 270012
- 270013
- 270014
- 270015
- 270016
- 270017
Distribution
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