FDA Device recall Z-0804-2015
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
- FDA Device
- Class III
- terminated
- Published 2014-12-24
On 2014-12-24 the FDA classified a Class III recall of 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 by Agfa Healthcare, citing some material of the coating Type CXCPMV3 has potential artifacts showing a small bright thin line when the film is processed.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0804-2015 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2014-10-24 |
| Published | 2014-12-24 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Agfa Healthcare |
| Distribution | US |
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
Some material of the coating Type CXCPMV3 has potential artifacts showing a small bright thin line when the film is processed.
Identifiers
| code_info | Lot 79440009 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0804-2015%22
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