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
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- GE HealthCare
- Product type
- Nuclear medicine gamma camera
- Model numbers
- Millenium MG/MC
- Sold at
- Unknown
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
September 12, 2025
Reported by FDA DEVICE
October 29, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
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
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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Product Details
Model: Millenium MG/MC dual-head gamma camera. Units recalled: 1,386. Distribution: Worldwide.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Detector mounting risk can lead to a detector fall
- Notification by letter
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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