FDAHealthSeptember 12, 2025
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING — Optima NX; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
⚠️ 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.
Is this relevant to me?
- Geography
- Unknown
- Source agency
- FDA
- Category
- Health
- Published
- September 12, 2025
Worldwide
What's affected?
- Product
- Optima NX; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
- Lot code
- all serial numbers in distribution
Additional details
all serial numbers in distribution
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 1 unit.
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