Drug recall
Elscint Cardial; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
FDA recall event 97647 · Class II · GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Key facts
| Event ID | 97647 |
|---|---|
| Recall numbers | Z-0290-2026, Z-0291-2026, Z-0292-2026, Z-0293-2026, Z-0294-2026, Z-0295-2026, Z-0296-2026, Z-0297-2026, Z-0298-2026, Z-0299-2026, Z-0300-2026, Z-0301-2026 and 2 more |
| Recalling firm | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING |
| Product type | Devices |
| Products | Elscint Cardial; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging, Elscint Helix; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging, Elscint Model 4XX; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging, Elscint SPX4; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging, Elscint SPX6; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging and 9 more |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated without adequate detector support. This could… |
| Initiation date | Sep 12, 2025 |
| Report date | Oct 29, 2025 |
| City | Haifa |
| Country | Israel |
| FEI number | 3027338963 |
At a glance
- 10–99 Products in this recall
- None 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: