Virtual Imaging RadPRO Mobile X-Ray System Recalled for Mount Separation Risk
Virtual Imaging is recalling 253 RadPRO Mobile 40kW Digital X-Ray Systems because the tube head may separate and fall off the unit.
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 (falling heavy equipment) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Virtual Imaging, Inc. is recalling 253 units of the RadPRO Mobile 40kW Digital X-Ray System, Model SM-40HF-B-D-C. The recall is due to a potential defect where the tube head may separate from the Tube Head Mount and fall off the system.
The affected units were distributed worldwide, including the United States, Canada, and Italy. The instrument is used to take diagnostic radiographic exposures of various body parts on adult and pediatric subjects.
Consumers and healthcare facilities should check their inventory for the specific model and serial codes listed in the official recall notice. If a unit is affected, it should be removed from service and the manufacturer contacted for instructions on repair or replacement.
The recalled product
- Product
- RadPRO(R) Mobile 40kW Digital X-Ray System - Model: SM-40HF-B-D-C Product Usage: Instrument is used to take diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts on both adult and pediatric subjects. Applications…
- Manufacturer
- Virtual Imaging, Inc.
- Affected units
- 253
Distribution
Distributed nationwide across the United States.
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