Radiomat M+ NIF 14 x 17 — Class III medical device recall Z-0804-2015
Terminated recall by AGFA Healthcare Corp., reported 2014-12-24, distributed nationwide. Some material of the coating Type CXCPMV3 has potential artifacts showing a small bright thin line when the fi
| Recall number | Z-0804-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | AGFA Healthcare Corp., Greenville, SC, United States |
| Recall initiated | 2014-10-24 |
| Classified | 2014-12-15 |
| Reported by FDA | 2014-12-24 |
| Terminated | 2015-03-16 |
| Distributed | Nationwide (US) |
| Quantity | 142 units |
| Lot numbers | 79440009 |
Product
Radiomat M+ NIF 14 x 17, Radiomat M+ NIF 35CM x 43CM, Radiomat M+ NIF 10 x 12, Radiomat M+ NIF 25,4CM x 30,5CM
Reason for recall
Some material of the coating Type CXCPMV3 has potential artifacts showing a small bright thin line when the film is processed.
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-0804-2015. 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.