FDAFDA · Food and drugs·Recall number Z-0299-2026
Millenium MPR; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
Published October 29, 2025 · Recall initiated: September 12, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
- Distributor
- Worldwide
- Lot
- all serial numbers in distribution
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Israel
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