Drug recall
Philips Essenta DR, a Stationary x-ray system, X-ray system Model: 712070 The Essenta DR is a multifunctional…
FDA recall event 67012 · Class II · Philips Medical Systems, Inc.
Key facts
| Event ID | 67012 |
|---|---|
| Recall numbers | Z-0584-2014 |
| Recalling firm | Philips Medical Systems, Inc. |
| Product type | Devices |
| Products | Philips Essenta DR, a Stationary x-ray system, X-ray system Model: 712070 The Essenta DR is a multifunctional stationary X-ray system, in which the swivel arm rotation, the vertical movement of the… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | X-ray system C-arm casting may loosen and fall |
| Initiation date | Dec 5, 2013 |
| Report date | Jan 8, 2014 |
| Termination date | Jan 17, 2017 |
| City | Andover |
| State | MA |
| Country | United States |
| FEI number | 1218950 |
At a glance
- 1–9 Products in this recall
- None 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: