FDA Device recall Z-2178-2014
Radiomat M+ NIF 14 x 17
- FDA Device
- Class III
- terminated
- Published 2014-08-20
On 2014-08-20 the FDA classified a Class III recall of Radiomat M+ NIF 14 x 17 by Agfa Healthcare, citing some sheets of the medical screen film are fogged.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2178-2014 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2014-07-16 |
| Published | 2014-08-20 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Agfa Healthcare |
| Distribution | US |
Product
Radiomat M+ NIF 14 x 17; Radiomat SG 14 x 17 NIF; RX-B 8 x 10 in./IBF-004355; Radiomat B+ NIF 14 x 17; Radiomat B+ NIF 8 x 10; Radiomat B+ NIF 9 1/2 x 9 1/2; CX Ultra UV-G Plus NIF 11 x 14; Radiomat G Plus 14 x 17 NIF Product Usage: Radiographic film is a device that consists of a thin sheet of radiotransparent material coated on one or both sides of the film, with a radiotransparent material coated on one or both sides of the film, with a photographic emulsion intended to record images during diagnostic radiologic procedures.
Reason
Some sheets of the medical screen film are fogged.
Identifiers
| code_info | Lot Batch No. 79350052, 79380052, 79390074, 79400066, 79410063 |
|---|
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-2178-2014%22
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