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
- Nuclear medicine gamma camera
- Model numbers
- All serial numbers in distribution
- 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 Elscint SPX6 is a dual-head gamma camera used in nuclear medicine for cardiac imaging. It is part of advanced imaging used in diagnostic radiology.
Why This Is Dangerous
If transported without proper detector support, mounting stress can compromise detector integrity, potentially causing a detector fall with life-threatening implications.
Industry Context
This recall is not described as part of a broader industry pattern in the provided data.
Real-World Impact
Hospitals and clinics may need to halt imaging using affected units and coordinate with the manufacturer for service or replacement to prevent patient harm.
Practical Guidance
How to identify if yours is affected
- Verify if your facility owns an Elscint SPX6 gamma camera.
- Confirm serial numbers: all serial numbers in distribution are affected.
- Review the recall notice and contact the manufacturer for instructions.
Where to find product info
Recall notice and contact details are available on the FDA enforcement page linked in the data.
What timeline to expect
No timeline is provided in the data; follow the manufacturer's instructions for service or recall actions.
If the manufacturer is unresponsive
- Document all communications with the manufacturer.
- Escalate to hospital risk management or regulatory affairs if the manufacturer is slow to respond.
How to prevent similar issues
- Ensure transport and relocation procedures follow detector mounting guidance.
- Maintain service records and verify End of Guaranteed Service status before moving equipment.
- Verify recall participation and obtain written instructions before resuming use after service.
Documentation advice
Keep the recall notice, service correspondence, and any technician reports as part of compliance and safety records
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Product Details
Model: Elscint SPX6. All serial numbers in distribution. Sold worldwide. No individual price data available.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 28 units affected worldwide
- Elscint SPX6 dual-head gamma camera
- Detectors may suffer mounting stress leading to potential detector fall
- End of Guaranteed Service context
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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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