Shimadzu Recalls Mobile X-ray Systems for Beam Quality Non-Compliance
Shimadzu Medical Systems is recalling 133 mobile X-ray systems because certain units may not meet federal beam quality standards.
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, which typically corresponds to a moderate severity. The source text does not report any illnesses, injuries, or deaths, and the hazard is a regulatory non-compliance regarding beam quality standards rather than an immediate physical danger like fire or choking.
Plain-English summary
Shimadzu Medical Systems is recalling 133 units of the 0.7/1.3U163CS-36 mobile X-ray system, used in combination with MobileArt Evolution and MobileDaRt Evolution systems. These devices are used to take general radiography of patients in hospitals who cannot move and outpatients in emergency settings. The recall covers units distributed nationwide in the United States.
The recall is issued because the devices do not comply with Product Performance Standards, specifically 21CFR 1020.30 (m) regarding beam quality and half-value layer (HVL). The standards were revised in 2006, and certain devices might not comply with the requirements in some X-ray generating conditions after this revision.
Healthcare facilities should identify affected units by checking the X-ray tube serial numbers listed in the recall notice. Shimadzu Medical Systems is the recalling firm responsible for the recall.
The recalled product
- Product
- 0.7/1.3U163CS-36 In combination with below systems MobileArt Evolution, MobileDaRt Evolution Product Usage: The device is a mobile X-ray system in order to take general radiography of patients in the hospital who cannot move and/or of outpatients in emergency.
- Manufacturer
- Shimadzu Medical Systems
- Affected units
- 133
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 recalled by Shimadzu Medical Systems under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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