Quick Facts at a Glance
- Recall Date
- September 12, 2025
- Hazard Level
- HIGH
- Brands
- 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
- 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 Cardial dual-head gamma camera is a nuclear medicine device used for cardiac imaging. It captures functional information about heart tissue to help diagnose conditions.
Why This Is Dangerous
If the detector mounting is stressed during transport or relocation and fails, a detector could detach and fall, creating a risk of life-threatening injury.
Industry Context
This recall is not described as part of a broader industry pattern in the notice.
Real-World Impact
The recall affects healthcare facilities globally. The immediate risk is to patients and staff should a detector fall occur during handling or relocation.
Practical Guidance
How to identify if yours is affected
- Verify device identity as Elscint Cardial dual-head gamma camera.
- Confirm device serial numbers are among those in distribution (all serial numbers affected).
- Check recall correspondence for mandated actions by GE Medical Systems Israel or Functional Imaging.
Where to find product info
Recall letter from GE and FDA enforcement page linked in notice. Identifiers can also be on the device label or service records.
What timeline to expect
Manufacturer communications will provide timelines for remedies which may involve inspections, repairs, or replacements.
If the manufacturer is unresponsive
- Escalate to hospital procurement or biomedical engineering leadership.
- Notify GE Medical Systems Israel or Functional Imaging if there is no response within the stated timeframe.
How to prevent similar issues
- Ensure devices undergoing transport have proper detector support and mounting hardware.
- Establish documented service and transport protocols to prevent stress on detector mounts.
- Verify future service while devices are within the guaranteed service window.
Documentation advice
Document all communications with GE, any corrective actions, and any incident reports related to device handling.
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
Product Details
Product: Elscint Cardial dual-head nuclear medicine gamma camera for cardiac imaging Brand: GE Medical Systems Israel / Functional Imaging Quantity recalled: 11 units Distribution: Worldwide Sold from: Unknown Price: Unknown Model numbers: All serial numbers in distribution
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Product: Elscint Cardial dual-head gamma camera
- Hazard: detector mounting stress leading to possible detector fall
- Distribution: Worldwide with all serial numbers affected
Browse More Recalls
Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
Read: What to Do When You Find a Recalled ProductGet Alerts for Health & Personal Care Recalls
Get instant alerts for recalls that affect you. Free forever.