Class III — AGFA Healthcare Corp.
| Recalling firm | AGFA HEALTHCARE N.V. |
|---|---|
| Registered facility | View this company's 4 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class III |
| Status | Terminated |
| Reason | Unit was mislabeled with a factory label showing 32 KW output power. |
| Product | Agfa Digital Radiography X-Ray System DX-D 100 Product Usage: Is indicated for use in providing diagnostic quality images to aid the physician with diagnoses. |
| Quantity | 1 |
| Distribution | US in the state of WV |
| Initiated | 2014-05-13 |
| Classified | 2014-08-09 |
| Terminated | 2014-08-13 |
| Recall number | Z-2176-2014 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class III recall — AGFA Healthcare Corp. (Z-2176-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/68798/
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