Drug recall
Intended for both adult and pediatric patients for taking diagnostic radiographic exposures of the skull…
FDA recall event 67869 · Class II · Philips Medical Systems, Inc.
Key facts
| Event ID | 67869 |
|---|---|
| Recall numbers | Z-0508-2015 |
| Recalling firm | Philips Medical Systems, Inc. |
| Product type | Devices |
| Products | Intended for both adult and pediatric patients for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts on both adult and pediatric… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | In special cases, during the start-up of the current model of MobileDiagnost wDR(WmDR 1.1), an unintended exposure could occur. |
| Initiation date | Apr 8, 2014 |
| Report date | Dec 24, 2014 |
| Termination date | May 31, 2018 |
| 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: