Millenium MPS; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
Reported: October 29, 2025 Initiated: September 12, 2025 #Z-0300-2026
Product Description
Millenium MPS; 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.
Details
- Recalling Firm
- GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
- Units Affected
- 54 units
- Distribution
- Worldwide
- Location
- Haifa
Frequently Asked Questions
What product was recalled? ▼
Millenium MPS; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging. Recalled by GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING. Units affected: 54 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 29, 2025. Severity: Moderate. Recall number: Z-0300-2026.
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