Shimadzu Recalls Mobile X-ray Systems for Beam Quality Non-Compliance
Shimadzu Medical Systems is recalling 5 mobile X-ray systems because they may not meet federal beam quality standards.
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, but the source text does not report any injuries, illnesses, or hospitalizations. 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 harm.
Plain-English summary
Shimadzu Medical Systems is recalling 5 units of its MobileArt Evolution mobile X-ray systems, including the Diagnostic X-ray Beam-Limiting Device and Diagnostic x-ray tube assembly. The recall covers specific serial numbers for both 12.5 kW and 32 kW models.
The devices are being recalled because they do not comply with the Product Performance Standards, 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.
The affected units were distributed nationwide in the US. The source text does not specify the exact number of affected patients or report any injuries or illnesses. Consumers and healthcare facilities should contact Shimadzu Medical Systems for further instructions on how to address the non-compliance.
The recalled product
- Product
- 0.7/1.2JG326D-265 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
- 5
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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