Drug recall
Philips brand IntelliSpace PACS 4.4, Image Management System; The system is a software package used with…
FDA recall event 66560 · Class II · Philips Healthcare Informatics, Inc.
Key facts
| Event ID | 66560 |
|---|---|
| Recall numbers | Z-0269-2014 |
| Recalling firm | Philips Healthcare Informatics, Inc. |
| Product type | Devices |
| Products | Philips brand IntelliSpace PACS 4.4, Image Management System; The system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Philips Healthcare became aware of a software problem with the IntelliSpace PACS system, in that a timing issue has been identified that may result in a condition where the device does not store… |
| Initiation date | Oct 14, 2013 |
| Report date | Nov 20, 2013 |
| Termination date | Jun 11, 2014 |
| City | Foster City |
| State | CA |
| Country | United States |
| FEI number | 3002971142 |
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: