Drug recall
1.5T and 3.0T SIGNA HDx, 1.5T and 3.0T SIGNA HDxt, and 1.5T SIGNA HDxt Mobile. Magnetic Resonance Imaging…
FDA recall event 89720 · Class II · GE Healthcare, LLC
Key facts
| Event ID | 89720 |
|---|---|
| Recall numbers | Z-0857-2022, Z-0858-2022, Z-0859-2022, Z-0860-2022 |
| Recalling firm | GE Healthcare, LLC |
| Product type | Devices |
| Products | 1.5T and 3.0T SIGNA HDx, 1.5T and 3.0T SIGNA HDxt, and 1.5T SIGNA HDxt Mobile. Magnetic Resonance Imaging System, 1.5T SIGNA Excite HD, 3.0T SIGNA Excite HD. Magnetic Resonance Imaging System, Signa 1.5T TwinSpeed Magnetic Resonance Imaging System, SIGNA Excite 3T. Magnetic Resonance Imaging System |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | There is potential for the images to be flipped left to right. |
| Initiation date | Feb 18, 2022 |
| Report date | Apr 13, 2022 |
| 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: