High FDA (Devices)·Z-1487-2013·Announced 2013-06-12

AGFA DX-D 100 X-Ray System Recalled for Unintended Movement

AGFA Corp. is recalling 104 DX-D 100 digital radiography systems because they may experience intermittent, unintended, and illogical movement during use.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a risk of unintended movement that could potentially cause harm, but no specific injuries or illnesses are reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

AGFA Corp. is recalling 104 units of the AGFA Digital Radiography X-Ray System DX-D 100. The recall was initiated because customers could potentially experience intermittent, unintended, and illogical movement when using the product.

The affected systems are indicated for use in providing diagnostic quality images to aid physicians with diagnosis, including radiographic images of the skeleton, chest, abdomen, and other body parts. The recall covers units distributed worldwide, including nationwide in the United States and in Canada.

Customers should contact AGFA Corp. for further instructions on how to address the issue. The specific material numbers for the affected units in the US are 5Q82F, 5R75Q, 5Q8ZB, 5R77U, and 58Q1D, while the material numbers in Canada are 5R78W and 5R77U.

The recalled product

Product: AGFA Digital Radiography X-Ray System DX-D 100 Agfa's DX-D 100 is indicated for use in providing diagnostic quality images to aid the physician with diagnosis. Systems can be used with MUSICA2 image processing to create radiographic images of the skeleton including skull, spin
Manufacturer: AGFA Corp.
Category: Medical Device — Radiography Equipment
Hazard: unintended-movement
Affected units: 104

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 (4)

Material numbers in US - 5Q82F
5R75Q
5Q8ZB
5R77U & 58Q1D - Material numbers in Canada - 5R78W & 5R77U

Distribution

Distributed nationwide across the United States.

The notice also names 22 states specifically:

Same manufacturer · AGFA Corp.

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Same hazard · unintended movement