Drug recall
The Claymount Harmony is a grid cabinet designed to accept a digital x-ray imaging receptor and stationary…
FDA recall event 67713 · Class II · Claymount Assembli
Key facts
| Event ID | 67713 |
|---|---|
| Recall numbers | Z-1835-2014 |
| Recalling firm | Claymount Assembli |
| Product type | Devices |
| Products | The Claymount Harmony is a grid cabinet designed to accept a digital x-ray imaging receptor and stationary grid. It contains signaling electronics to indicate the presence of the grid and detector as… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Harmony1 models of the Harmony Bucky is incorrectly labeled in that the label does not list the manufacturer address, the date of manufacture, or a statement of compliance with 21 CFR Subchapter J. |
| Initiation date | Mar 15, 2014 |
| Report date | Jul 9, 2014 |
| Termination date | Oct 18, 2018 |
| City | Dinxperlo |
| Country | Netherlands |
| FEI number | 3006383214 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: