Shimadzu Recalls Mobile X-ray Systems for Beam Quality Non-Compliance
Shimadzu is recalling 288 mobile X-ray systems and related components because they may not meet federal standards for beam quality.
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, but the source text does not report any hospitalizations, injuries, or illnesses. The hazard is a regulatory non-compliance regarding beam quality standards, which fits the criteria for a moderate severity score in the absence of reported adverse health consequences.
Plain-English summary
Shimadzu Medical Systems is recalling 288 units of Diagnostic X-ray Beam-Limiting Devices, Mobile X-ray Systems, and Diagnostic X-ray Tube Assemblies. The affected products include the MUX-100H, MUX-100D, and MobileArt Evolution systems, which are used to take general radiography of patients in hospitals and emergency settings. The recall covers units distributed nationwide in the United States.
The recall was initiated because the devices do not comply with Product Performance Standards, specifically 21CFR 1020.30 (m) regarding beam quality and half-value layer (HVL). These standards were revised in 2006, and certain devices may not meet the requirements under some X-ray generating conditions following that revision.
Healthcare facilities and users should identify affected units by checking the serial numbers of the X-ray tubes against the list provided in the official recall notice. Users should contact Shimadzu Medical Systems for further instructions on how to address the non-compliance.
The recalled product
- Product
- 0.7U163CS-36 In combination with below systems MUX-100H, MUX-100D, MobileArt Evolution Brand Name: MUX-100H. Classification Name: Mobile x-ray system. Device Model#MUX-100H. Product Usage: The device is a mobile X-ray system in order to take general radiography of
- Manufacturer
- Shimadzu Medical Systems
- Affected units
- 288
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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