Drug recall
Centricity PACS-IW with Universal Viewer Product Usage: Usage: Centricity PACS-IW with Universal Viewer is a…
FDA recall event 80159 · Class II · GE Healthcare
Key facts
| Event ID | 80159 |
|---|---|
| Recall numbers | Z-2101-2018, Z-2102-2018 |
| Recalling firm | GE Healthcare |
| Product type | Devices |
| Products | Centricity PACS-IW with Universal Viewer Product Usage: Usage: Centricity PACS-IW with Universal Viewer is a device that displays medical images (including mammograms) and data from various imaging…, Centricity Universal Viewer Product Usage: Usage: Centricity PACS-IW with Universal Viewer is a device that displays medical images (including mammograms) and data from various imaging sources. Images… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Potential that one or more image series may be missing from an exam without a user warning displayed in the Viewer. |
| Initiation date | Jan 25, 2018 |
| Report date | Jun 13, 2018 |
| Termination date | Nov 2, 2023 |
| City | Chicago |
| 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: