Drug recall
Discovery IQ Product Usage: The systems are intended for head and whole body attenuation corrected Positron…
FDA recall event 82982 · Class II · GE Healthcare, LLC
Key facts
| Event ID | 82982 |
|---|---|
| Recall numbers | Z-1745-2019, Z-1746-2019, Z-1747-2019, Z-1748-2019, Z-1749-2019, Z-1750-2019 |
| Recalling firm | GE Healthcare, LLC |
| Product type | Devices |
| Products | Discovery IQ Product Usage: The systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy…, Discovery Ml DR Product Usage: The systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient…, Discovery Ml Product Usage: The systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy…, Discovery PET/CT 610 Product Usage: The systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient…, Discovery PET/CT 710 Product Usage: The systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient… and 1 more |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | FDA Requested |
| Reason for recall | GE Healthcare PET/CT Table Stop Without Stopping X-Ray Exposure |
| Initiation date | Feb 12, 2019 |
| Report date | Jun 26, 2019 |
| 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: