Elscint Helix; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
| Source | FDA Device Enforcement |
|---|---|
| Category | Medical Device |
| Severity | Medium |
| Status | ongoing |
| Recall date | September 12, 2025 |
| Reported | October 29, 2025 |
| Recalling firm | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING |
| Country / region | Israel Worldwide |
Hazard
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 result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.
Affected products
- Elscint Helix; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
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