Drug recall
Revolution CT ES - Product Usage: intended for head, whole body, cardiac and vascular X-ray Computed…
FDA recall event 86932 · Class II · GE Healthcare, LLC
Key facts
| Event ID | 86932 |
|---|---|
| Recall numbers | Z-0694-2021, Z-0695-2021 |
| Recalling firm | GE Healthcare, LLC |
| Product type | Devices |
| Products | Revolution CT ES - Product Usage: intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications., Revolution CT with Apex Edition CT System - Product Usage: intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | A potential for protocol(s) with unintended patient orientation or scan setting when using Intelligent Protocoling |
| Initiation date | Nov 23, 2020 |
| Report date | Dec 30, 2020 |
| Termination date | Aug 29, 2023 |
| 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: