Shimadzu Digital Radiography X-Ray System Recalled for Image Loss
Shimadzu Medical Systems is recalling its Digital Radiography X-Ray System because a report was received regarding lost images under certain circumstances.
What this means for you
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 functional defect (lost image) without reported injuries or deaths, fitting the criteria for a moderate severity recall.
Plain-English summary
Shimadzu Medical Systems is recalling the Shimadzu Digital Radiography X-Ray System, Catalog No. DAR-8000f. This device is intended to be used for radiography in the hospital with X-ray devices.
The recall was initiated because the manufacturer received a report of a lost image under certain circumstances. The recall covers 685 units total, with 14 units distributed in the United States. The product was distributed nationwide in the US as well as in Japan, China, Germany, Australia, Thailand, Sri Lanka, South Africa, UAE, Saudi Arabia, Korea, and Taiwan.
Hospitals and medical facilities should contact Shimadzu Medical Systems for further instructions regarding the recall and any necessary corrective actions.
The recalled product
- Product
- Shimadzu Digital Radiography X-Ray System, Catalog No. DAR-8000f. This device is intended to be used for radiography in the hospital with X-ray devices.
- Manufacturer
- Shimadzu Medical Systems
- Hazard
Distribution
Distributed nationwide across the United States.
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