Quick Facts at a Glance
- Recall Date
- September 12, 2025
- Hazard Level
- HIGH
- Brand
- GE Medical Systems Israel, Functional Imaging
- 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 Medical Systems Israel, Functional Imaging
- Product type
- Nuclear Medicine Gamma Camera
- Model numbers
- Millenium MPS
- 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 Millennium MPS is a dual-head gamma camera used in cardiac nuclear imaging to assess myocardial perfusion.
Why This Is Dangerous
If the device is moved without proper detector support, mounting may fail and detectors could fall, risking patient injury.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Hospitals may need to suspend certain cardiac imaging procedures and arrange for service or replacement.
Practical Guidance
How to identify if yours is affected
- Confirm the device model is Millennium MPS dual-head gamma camera.
- Verify serial numbers are in distribution (all serial numbers).
- Review the manufacturer's recall notification.
- If affected, stop using the device immediately.
Where to find product info
FDA enforcement page for recall Z-0300-2026; GE Medical Systems Israel recall notices.
What timeline to expect
4-8 weeks for remedy processing and replacement arrangements.
If the manufacturer is unresponsive
- Escalate to hospital risk management.
- File a complaint with FDA CDRH recall program.
- Consult legal counsel if patient injuries or delays occur.
How to prevent similar issues
- Maintain current service agreements for imaging devices.
- Establish relocation procedures and proper mounting checks before moving equipment.
- Monitor recall notices from FDA and manufacturer.
Documentation advice
Keep recall letters, serial numbers, photos, and all communications for records.
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Product Details
Model: Millennium MPS dual-head gamma camera; Sold worldwide to healthcare facilities; Sold date: Unknown; Price: Unknown.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 54 units recalled worldwide
- Model: Millennium MPS dual-head gamma camera
- All serial numbers in distribution
- Potential detector mounting failure could lead to detector fall
- Remedy: stop use immediately; follow manufacturer instructions
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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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