The Recall Desk
ModerateFDA (Devices)·Z-0261-2013·Announced 2012-11-14

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

Shimadzu is recalling 308 R-20J Diagnostic X-Ray Beam-Limiting Devices because they may not meet 2006 FDA performance 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. It is a compliance issue regarding performance standards rather than a direct safety hazard with reported harm.

Plain-English summary

Shimadzu Medical Systems is recalling 308 units of the R-20J Diagnostic X-Ray Beam-Limiting Device. These devices are used in combination with specific X-ray tubes (06/1.2P364DK-85, 0.6/1.2P324DK-125, 06/1.2P324DK-85, and 0.6/1.2P38DE-85) for X-ray radiography. The recall covers devices distributed nationwide in the United States.

The recall was initiated because the devices do not comply with FDA 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 may not meet the updated requirements under some X-ray generating conditions.

This recall is classified as Class II by the FDA. No specific instructions for consumers are provided in the source text, but affected facilities should contact the manufacturer for further guidance.

The recalled product

Product
R-20J , Diagnostic X-Ray Beam-Limiting Device. In combination with any of below X-Ray tubes: 06/1.2P364DK-85, 0.6/1.2P324DK-125, 06/1.2P324DK-85, 0.6/1.2P38DE-85. Product Usage: The device is the beam-limiting device for X-ray Radiography.
Manufacturer
Shimadzu Medical Systems
Category
Medical Device — Diagnostic Imaging
Hazard
Affected units
308

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-20J

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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