Drug recall
1.5T SIGNA HDxt MR System nuclear magnetic resonance imaging system
FDA recall event 88665 · Class II · GE Healthcare, LLC
Key facts
| Event ID | 88665 |
|---|---|
| Recall numbers | Z-0132-2022, Z-0133-2022, Z-0134-2022, Z-0135-2022, Z-0136-2022, Z-0137-2022, Z-0138-2022, Z-0139-2022, Z-0140-2022, Z-0141-2022 |
| Recalling firm | GE Healthcare, LLC |
| Product type | Devices |
| Products | 1.5T SIGNA HDxt MR System nuclear magnetic resonance imaging system, Discovery MR750 3.0T nuclear magnetic resonance imaging system, Discovery MR750w 3.0T nuclear magnetic resonance imaging system, Optima MR450w 1.5T nuclear magnetic resonance imaging system, SIGNA Architect nuclear magnetic resonance imaging system and 5 more |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images. |
| Initiation date | Aug 26, 2021 |
| Report date | Oct 27, 2021 |
| City | Waukesha |
| State | WI |
| Country | United States |
| FEI number | 2126677 |
At a glance
- 10–99 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: