Moderate FDA (Devices)·Z-1738-2017·Announced 2017-04-12

Agfa Healthcare Recalls DX-D600 Imaging Packages Due to Dent Marker Defect

Agfa Healthcare is recalling 81 DX-D600 imaging packages because a dent marker may fall from the overhead rail.

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, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The specific defect involves a component dropping from an overhead rail, representing a potential physical hazard without reported injuries.

Plain-English summary

Agfa Healthcare Corp. is recalling 81 units of the DX-D600 DXD Imaging Package. The recall was initiated because one of the dent markers from the device dropped down from the overhead rail.

The affected units were distributed in Alabama, California, the District of Columbia, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Minnesota, Missouri, Nevada, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, South Carolina, Tennessee, Texas, Virginia, and Canada.

Consumers and healthcare facilities should contact Agfa Healthcare Corp. for further instructions regarding the recall and replacement of the affected units.

The recalled product

Product: DX-D600 - DXD Imaging Package
Manufacturer: AGFA Healthcare Corp.
Category: Medical Device — Imaging Equipment
Hazard: falling-object
Affected units: 81

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 (20)

A5430000264
A5430000272
A5430000162
A5430000238
A5430000226
A5430000137
A5430000306
A6430000298
A5430000299
A5430000246
A5430000247
A5430000249
A5430000303
A5430000228
A5430000229
A5430000304
A5430000234
A5430000276
A5430000285
A5430000296

Distribution

Distributed in 24 states:

Same manufacturer · AGFA Healthcare Corp.

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Same hazard · falling object