The Recall Desk
ModerateFDA (Devices)·Z-0260-2013·Announced 2012-11-14

Shimadzu Recalls Diagnostic X-Ray Beam-Limiting Devices for Performance Non-Compliance

Shimadzu Medical Systems is recalling 665 R-30H Diagnostic X-Ray Beam-Limiting Devices because they may not comply with 2006 product performance standards regarding 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 compliance issue with performance standards rather than a direct, reported physical injury, fitting the criteria for a moderate severity score.

Plain-English summary

Shimadzu Medical Systems is recalling 665 units of the R-30H Diagnostic X-Ray Beam-Limiting Device. This device is used in combination with specific X-ray tubes (models 0.6/1.2P364DK-85, 0.6/1.2P324DK-125, 0.6/1.2P324DK-85, and 0.6/1.2P38DE-85) for X-ray radiography. The recall also covers Mobile x-ray systems and Diagnostic x-ray tube assemblies associated with these devices.

The recall was initiated because the devices do not comply with the Product Performance Standards found in 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.

The affected devices were distributed nationwide in the United States. No specific illnesses or injuries are reported in the source text. Healthcare facilities and users of these devices should contact Shimadzu Medical Systems for further instructions on how to address the non-compliance.

The recalled product

Product
R-30H , Diagnostic X-Ray Beam-Limiting Device. In combination with any of below X-ray tubes 0.6/1.2P364DK-85, 0.6/1.2P324DK-125, 0.6/1.2P324DK-85, 0.6/1.2P38DE-85 Device Model # R-30H. Subsequent Product Code: IZX Product Usage: The device is the beam-limiting
Manufacturer
Shimadzu Medical Systems
Category
Medical Device — Diagnostic Imaging
Hazard
Affected units
665

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Device Model #R-30H

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 →

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