Agfa Digital Radiography X-Ray System DX-D 100 Product Usage: Is… — Class III medical device recall Z-2176-2014
Terminated recall by AGFA Healthcare Corp., reported 2014-08-20, distributed in WV. Unit was mislabeled with a factory label showing 32 KW output power.
| Recall number | Z-2176-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | AGFA Healthcare Corp., Greenville, SC, United States |
| Recall initiated | 2014-05-13 |
| Classified | 2014-08-09 |
| Reported by FDA | 2014-08-20 |
| Terminated | 2014-08-13 |
| Distributed | WV |
| Quantity | 1 |
| Reason classes | labeling |
| Serial numbers | A5410000042 |
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.
Reason for recall
Unit was mislabeled with a factory label showing 32 KW output power.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2176-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.