Drug recall
Centricity Cardio Imaging 5.0 is a software only Picture Archiving and Communication System (PACS). Product…
FDA recall event 64787 · Class II · GE Healthcare It
Key facts
| Event ID | 64787 |
|---|---|
| Recall numbers | Z-0034-2014 |
| Recalling firm | GE Healthcare It |
| Product type | Devices |
| Products | Centricity Cardio Imaging 5.0 is a software only Picture Archiving and Communication System (PACS). Product Usage: It will be sold as a software only device to operate on general purpose computing… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | GE Healthcare is aware of a potential safety risk where an image labeling situation exists in the Image Viewer software of the Centricity Cardio Imaging product, version 5.0 SP1. Multiple studies may… |
| Initiation date | Oct 2, 2012 |
| Report date | Oct 30, 2013 |
| Termination date | May 16, 2016 |
| City | Barrington |
| State | IL |
| Country | United States |
| FEI number | 3004526608 |
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: