Drug recall
Precision 500D The Precision 500D R&F X-ray System is intended to be used as a universal diagnostic imaging…
FDA recall event 82668 · Class II · GE Healthcare, LLC
Key facts
| Event ID | 82668 |
|---|---|
| Recall numbers | Z-1751-2019, Z-1752-2019, Z-1753-2019, Z-1754-2019, Z-1755-2019 |
| Recalling firm | GE Healthcare, LLC |
| Product type | Devices |
| Products | Precision 500D The Precision 500D R&F X-ray System is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic examinations, including general R&F and pediatric…, Prestige II, Prestige SI, Prestige VH Prestige system is a new multi-purpose conventional and digital R/F remote controlled system., Prestilix 1600X Prestilix system is a fully integrated remote controlled digital radiology system. It is designed for all general radiology applications with or without contract injection and…, Proteus XR/a The Proteus XR/a radiographic system offers the flexibility to choose a configuration based upon your specific requirements. The system provides exceptional image quality, high frequency…, Silhouette VR This fully integrated system offers intuitive controls with advanced applications for maximum performance all in a space-saving design. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | There has been a reported incident of a Distar CRT monitor that has fallen off the monitor wall mount related to product aging. |
| Initiation date | Mar 29, 2019 |
| Report date | Jun 19, 2019 |
| Termination date | Apr 15, 2021 |
| City | Waukesha |
| State | WI |
| Country | United States |
| FEI number | 2126677 |
At a glance
- 1–9 Products in this recall
- 10–99 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: