Drug recall
Philips Multi Diagnost Eleva II
FDA recall event 69870 · Class II · Philips Medical Systems, Inc.
Key facts
| Event ID | 69870 |
|---|---|
| Recall numbers | Z-1044-2015, Z-1045-2015 |
| Recalling firm | Philips Medical Systems, Inc. |
| Product type | Devices |
| Products | Philips Multi Diagnost Eleva II, Philips Multi Diagnost Eleva with FlatDetector |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The possibility of the Reference Air Kerma Rate for low dose mode will not be reduced to 50% of the value for the normal mode, but will be approximately 70-80%, leading to a higher patient dose than… |
| Initiation date | Oct 14, 2013 |
| Report date | Mar 4, 2015 |
| Termination date | Jan 23, 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: