GE HealthCare Recalls 1,386 Millennium MG/MC Gamma Cameras for Detector Mounting Risk (2025)
GE HealthCare recalled 1,386 Millennium MG/MC dual-head gamma cameras used in cardiac imaging worldwide. The recall notes devices past End of Guaranteed Service may have been transported without adequate detector support, risking mounting failure and possible detector falls. Facilities should stop using the devices and await recall instructions sent by GE Medical Systems Israel, Functional Imaging
Quick Facts at a Glance
Recall Date
September 12, 2025
Hazard Level
HIGH
Brand
GE HealthCare
Category
Health & Personal Care
Sold At
Unknown
At-Risk Groups
GENERAL, CHILDREN, PREGNANT
Hazard Information
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 You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING or your healthcare provider for instructions. Notification method: Letter
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About This Product
Nuclear medicine gamma cameras are used in hospitals and imaging centers for cardiac imaging and other diagnostic studies.
Why This Is Dangerous
Moving or relocating units without proper detector mounting support can cause mounting stress and detector falls, risking life-threatening injuries.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Hospitals may experience downtime and must coordinate with GE HealthCare for service options to protect patient safety.
Practical Guidance
How to identify if yours is affected
Confirm model Millenium MG/MC is in use at your facility.
Check if the device is among the 1,386 units recalled.
Review the recall letter from GE HealthCare or GE Medical Israel Functional Imaging.
Where to find product info
Recall notice and FDA enforcement report Z-0297-2026; GE HealthCare customer support for instructions.
What timeline to expect
No refunds are described. Service, replacement, or loaner options will be arranged by GE HealthCare. Timelines vary by facility.
If the manufacturer is unresponsive
Document all communications and escalate to hospital risk management.
Consider filing a safety report with the appropriate health authority if GE HealthCare is unresponsive.
How to prevent similar issues
Require detector mounting checks during any future relocation
Ensure ongoing service contracts cover detector mounting components
Verify recall status before moving any nuclear medicine equipment
Documentation advice
Keep the recall letter, device serial numbers, photos, and all correspondence with GE HealthCare.
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