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.
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, 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.
- Hazard
- 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
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