Quick Facts at a Glance
- Recall Date
- September 12, 2025
- Hazard Level
- HIGH
- Brands
- GE Healthcare, 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 Healthcare, GE Medical Systems Israel, Functional Imaging
- Product type
- Gamma Camera
- Model numbers
- Millenium Myosight dual-head gamma camera
- 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 Myosight gamma camera is a dual-head nuclear medicine imaging device used to perform cardiac imaging studies in hospitals. It requires precise detector mounting to ensure accurate imaging.
Why This Is Dangerous
If the detector mounting is stressed due to improper handling, the detector could detach or fall, posing a serious risk to patients and staff.
Industry Context
This recall is not described as part of a broader industry-wide pattern.
Real-World Impact
Hospitals may experience equipment downtime and require service interventions. The recall pertains to life-threatening injury risk during transport or relocation of the device.
Practical Guidance
How to identify if yours is affected
- Verify device is a Millenium Myosight dual-head gamma camera.
- Confirm serial numbers are in distribution (all serial numbers).
- Check whether the device has recently been relocated or transported without appropriate mounting procedures.
Where to find product info
Serial numbers should be on the device label near the detector mounting and in the facility's service records.
What timeline to expect
Manufacturer guidance will specify remediation steps and timelines. Typical hospital remediation can span weeks to months depending on service parts.
If the manufacturer is unresponsive
- Escalate to hospital risk management and the national regulatory body if the manufacturer is slow to respond.
- Document all requests and responses with the manufacturer.
How to prevent similar issues
- Implement strict handling procedures for transporting nuclear imaging equipment.
- Verify detector mounting integrity during any relocation.
- Maintain up-to-date service records and end-of-life service status to identify risks earlier.
Documentation advice
Photograph device labels, keep the recall notice and correspondence, log serial numbers and relocation histories.
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Product Details
Product: Millenium Myosight dual-head gamma camera. Serial numbers: All serial numbers in distribution. Sold: Worldwide. Recall date: 2025-09-12. Price: Unknown.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Detectors could detach if mounting is stressed
- Active recall with high hazard level
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Safety Guide
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