Virtual Imaging Recalls Digital Mobile X-ray Systems Due to Motion Defect
Virtual Imaging, Inc. is recalling 316 digital mobile X-ray systems in the US and 6 in Canada due to a potential for unintended and erratic motion.
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 is classified as FDA Class II. The hazard involves unintended and erratic motion of a heavy medical device, which presents a risk of harm, but the source text does not report any injuries or illnesses.
Plain-English summary
Virtual Imaging, Inc. is recalling specific models of Digital Mobile X-ray Systems used for diagnostic radiographic exposures. The recall involves 316 units distributed in the United States and 6 units in Canada. The affected systems were distributed nationwide in the US to numerous states, as well as to a US Army facility in South Korea.
The recall is being conducted because there is a potential for unintended and erratic motion of the equipment. The source text does not report any specific injuries, illnesses, or fatalities associated with this defect.
Healthcare facilities and users should identify their equipment by checking the model and serial numbers against the list provided in the official recall notice. Affected units should be removed from service and the manufacturer contacted for further instructions.
The recalled product
- Product
- Digital Mobile X-ray Systems used to take diagnostic radiographic exposures or patients.
- Manufacturer
- Virtual Imaging, Inc.
- Hazard
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 (20)
- 1) Model: MOBILE 32KW ANALOG
- Serial Numbers: G29393
- G29395
- G29404
- G30236
- G30258
- G33309
- G33344
- G38069
- G38082
- G38711
- G38712
- G40196
- G40590
- G40989
- G41143
- G41163
- G60166
- G60169
- G60461
Distribution
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