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
- 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, GE Medical Systems Israel, Functional Imaging
- Product type
- Dual-head Nuclear Medicine Gamma Camera
- Model numbers
- Elscint Model 4XX
- 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
Nuclear medicine gamma cameras are used for specialized cardiac imaging to visualize physiological processes.
Why This Is Dangerous
If a unit is moved without proper support, the detector mounting can experience excessive stress, risking detector detachment and potential fall.
Industry Context
This recall is not described as part of a broader industry pattern in the provided information.
Real-World Impact
Hospitals may need to halt imaging procedures using affected cameras. Patient care workflows could be disrupted while units are evaluated or replaced.
Practical Guidance
How to identify if yours is affected
- Identify device as Elscint Model 4XX dual-head gamma camera.
- Confirm serial numbers are within distribution and that the unit is among those recalled.
- Check service or End-of-Guaranteed-Service status if available in your facility records.
- Refer to the recall letter for specific instructions from GE HealthCare.
Where to find product info
Recall notices and FDA enforcement listing are available at the provided FDA enforcement link (Z-0291-2026).
What timeline to expect
Timeline for remediation is not specified by the recall.
If the manufacturer is unresponsive
- Document all outreach attempts to GE HealthCare and hospital administration.
- Escalate to regulatory authorities if the vendor is unresponsive.
- Maintain records of all correspondence for compliance.
How to prevent similar issues
- Ensure transport and relocation of imaging equipment include proper detector mounting support.
- Maintain up-to-date service records and verify End-of-Guaranteed-Service status during moves.
- Follow manufacturer recall procedures for any equipment removals or relocations in the future.
Documentation advice
Keep recall notice, serial/model identifiers, transport records, and all correspondence as part of the device’s risk management file.
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Product Details
• Product: Elscint Model 4XX dual-head gamma camera • Brand: GE HealthCare • Units recalled: 64 • Distribution: Worldwide • Serial numbers: All serial numbers in distribution • Manufacturer: GE Medical Systems Israel, Functional Imaging • Recall date: 2025-09-12 • Remedy: Stop using the device and follow recall instructions • Status: Active
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- All serial numbers in distribution mentioned
- Detector mounting risk could lead to a detector fall
- Recall status: Active
- No injuries reported
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