Quick Facts at a Glance
- Recall Date
- September 12, 2025
- Hazard Level
- HIGH
- Brand
- GE Healthcare Israel Functional Imaging
- Category
- Health & Personal Care
- Sold At
- Unknown
- 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 Israel Functional Imaging
- Product type
- Dual-head Nuclear Medicine Gamma Camera
- Model numbers
- All serial numbers in distribution, Elscint Helix dual-head gamma camera
- Sold at
- Unknown
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 Helix is a dual-head gamma camera used for cardiac imaging in nuclear medicine. Hospitals rely on such devices for accurate diagnostic imaging.
Why This Is Dangerous
If relocated without adequate detector support after End of Guaranteed Service, the detector mounting can suffer excessive stress, risking detachment or falling of the detector.
Industry Context
This recall is not described as part of a broader industry pattern in the notice.
Real-World Impact
Hospitals must stop using the devices immediately. The recall affects three units worldwide, with potential imaging workflow disruptions until remedies are implemented and devices are replaced or repaired.
Practical Guidance
How to identify if yours is affected
- Verify device is the Elscint Helix dual-head gamma camera.
- Confirm the device belongs to the distribution list with all serial numbers in distribution.
- Review hospital service history to ensure relocation was performed with proper detector mounting support.
Where to find product info
Recall notice and manufacturer instructions provided by GE Healthcare Israel Functional Imaging. FDA recall page may have additional details.
What timeline to expect
Remedy timeline is not specified in the notice. Actions depend on manufacturer coordination with healthcare facilities.
If the manufacturer is unresponsive
- Escalate to hospital administration and risk management.
- Contact regulatory bodies if the manufacturer is slow to respond.
- Document all communications and actions taken.
How to prevent similar issues
- Institute strict relocation procedures for imaging equipment.
- Verify detector mounting integrity during any move.
- Maintain complete service records and end-of-service documentation.
- Verify that future service agreements require documented mounting checks.
Documentation advice
Keep the recall letter, correspondent communications, service reports, and replacement or repair receipts for records.
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Product Details
Product: Elscint Helix dual-head nuclear medicine gamma camera Serial numbers: All serial numbers in distribution Where sold: Worldwide distribution When sold: Unknown Price: Unknown
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 3 units recalled worldwide
- Model: Elscint Helix dual-head gamma camera (all serial numbers in distribution)
- Hazard: potential detector fall from mounting stress
- Remedy: stop use and follow manufacturer instructions
- Notification method: Letter
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Safety Guide
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