Shimadzu Mobile X-ray Systems Recalled for Image Transfer Issues
Shimadzu Medical Systems is recalling 297 Mobile X-ray systems because images may not transfer properly to the image server.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a software malfunction (image transfer) without reported injuries or deaths, fitting the criteria for a moderate severity issue.
Plain-English summary
Shimadzu Medical Systems is recalling 297 units of the Mobile X-ray system MobileDaRt Evolution/FDR Go Software. The device is a mobile X-ray system that allows technicians to take general digital radiography of patients in hospitals or medical facilities who cannot move, as well as outpatients in emergency settings.
The recall is being conducted because an image may not transfer to the image server properly. The affected units were distributed in the United States and internationally to Canada. Specific serial numbers for the affected units are listed in the official recall documentation.
Consumers and medical facilities should contact Shimadzu Medical Systems for further instructions regarding the recall and any necessary corrective actions.
The recalled product
- Product
- Mobile X-ray system MobileDaRt Evolution/FDR Go Software The device is a mobile X-ray system and allows a technician to take a general digital radiography of patients in the hospital or medical facility who cannot move and outpatients in emergency.
- Manufacturer
- Shimadzu Medical Systems
- Hazard
- Affected units
- 297
Distribution
Distribution scope not specified by the agency.
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