Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0265-2013·Announced 2012-11-14

Shimadzu Recalls Mobile X-ray Systems for Beam Quality Non-Compliance

Shimadzu Medical Systems is recalling 3 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, and the source text does not report any hospitalizations, injuries, or illnesses, fitting the criteria for a moderate severity score.

Plain-English summary

Shimadzu Medical Systems is recalling 3 units of the 0.4/0.7JG326D-265AX/AT mobile X-ray system. 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 Diagnostic X-ray Beam-Limiting Device, Mobile x-ray system, and Diagnostic x-ray tube assembly do not comply with 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.

Healthcare facilities should contact Shimadzu Medical Systems for further instructions on the recall. Specific serial numbers for the affected X-ray tubes are listed in the official recall documentation.

The recalled product

Product: 0.4/0.7JG326D-265AX/AT 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
Category: Medical Device — Diagnostic Imaging
Hazard: non-compliance
beam-quality
Affected units: 3

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.

See all 6 products in this recall →

Same manufacturer · Shimadzu Medical Systems

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