Quick Facts at a Glance
- Recall Date
- September 12, 2025
- Hazard Level
- HIGH
- Brand
- GE HealthCare
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- At-Risk Groups
- GENERAL
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
- Dual-head gamma camera
- Model numbers
- Millenium MPR
- Sold at
- Multiple Retailers
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
The Millenium MPR is a dual-head gamma camera used in nuclear medicine for cardiac imaging. Hospitals rely on these devices for myocardial perfusion imaging and similar procedures.
Why This Is Dangerous
If moved without proper detector mounting support, detector mounting could fail. A detector fall could cause life-threatening injuries to patients or staff.
Industry Context
This recall is not described as part of a broader industry pattern in the notice.
Real-World Impact
Hospitals and clinics with affected units must halt use and follow the recall instructions. The recall could disrupt imaging services and require equipment inspection or replacement.
Practical Guidance
How to identify if yours is affected
- Confirm the device is a Millenium MPR dual-head gamma camera.
- Assume all serial numbers are affected per the distribution note.
- Immediately stop using the device.
Where to find product info
Refer to the manufacturer's recall letter and the FDA enforcement page for Z-0299-2026. Check device labels for model information.
What timeline to expect
Remedies and replacement instructions will be communicated by GE HealthCare via letter; no general timeline is provided.
If the manufacturer is unresponsive
- Escalate to the hospital risk management or biomedical engineering department.
- Contact GE HealthCare through official channels for guidance.
- If needed, report to the appropriate regional health authority.
How to prevent similar issues
- Review and reinforce transport and relocation procedures for detector-based systems.
- Verify service status before moving any nuclear medicine equipment.
- Maintain up-to-date end-of-service assessments and service contracts.
Documentation advice
Keep the recall letter, model and serial information, and all communications with GE HealthCare. Document any actions taken and dates.
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Product Details
Product: Millenium MPR dual-head gamma camera. Model numbers: All serial numbers in distribution. Sold worldwide through medical distributors. When sold: Unknown. Price: Unknown.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 292 units recalled worldwide
- All serial numbers in distribution affected
- End-of-guaranteed-service status cited as context
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Safety Guide
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