Recall Z-0295-2026— GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Class II · Ongoing
Class II FDA medical device recall by GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING, initiated 2025-09-12. FDA's recall record names no specific 510(k) clearance for this event. Product: Elscint Helix; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging. Reason: 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..
- Recalling firm
- GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-09-12
- Firm location
- Haifa, Israel
Product description
Elscint Helix; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
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 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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.