Quick Facts at a Glance
- Recall Date
- September 12, 2025
- Hazard Level
- HIGH
- Brand
- GE Medical Systems Israel
- 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
- Product type
- Nuclear medicine gamma camera (dual-head)
- Model numbers
- Elscint SPX4
- 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 SPX4 is a dual-head nuclear medicine gamma camera used for cardiac imaging. Hospitals rely on these devices for functional imaging and diagnosis. The recall concerns post-service transport that may damage detector mounting components.
Why This Is Dangerous
If the detector mounting is stressed during transport or relocation without proper support, mounting integrity can fail. A detector fall could occur, potentially causing life-threatening injuries.
Industry Context
This recall is not indicated as part of a broader industry pattern at this time.
Real-World Impact
Hospitals could face urgent service interruptions or equipment replacement needs. The recall affects 45 units worldwide and may require on-site servicing or replacement to ensure patient safety.
Practical Guidance
How to identify if yours is affected
- Confirm model is Elscint SPX4.
- Verify the unit is among the 45 recalled worldwide.
- Check for End of Guaranteed Service status and past transport without detector mounting support.
Where to find product info
Refer to GE Medical Systems Israel Functional Imaging and the FDA recall page.
What timeline to expect
Recall actions and replacement timelines will be issued by GE Medical Systems Israel; no specific window is stated in the notice.
If the manufacturer is unresponsive
- Document all communications with GE Medical Systems Israel.
- Escalate to hospital regulatory affairs or applicable authorities if the vendor is slow to respond.
How to prevent similar issues
- Ensure service contracts specify on-site detector mounting support during transport.
- Request written service procedures for relocating imaging systems.
- Verify installation and relocation follow manufacturer guidelines and traceability.
- Check for regulatory recall histories before acquiring imaging equipment.
Documentation advice
Keep copies of all recall notices, communications with the manufacturer, service reports, and any equipment relocation records.
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Product Details
Model: Elscint SPX4. Distribution: Worldwide. Units recalled: 45. Serial numbers: All serial numbers in distribution. Sold at: Worldwide distribution. When sold: Not specified. Price: Unknown.
Reported Incidents
No injuries or incidents have been reported in connection with this recall.
Key Facts
- 45 units recalled worldwide
- Model: Elscint SPX4
- Past End of Guaranteed Service used in transport/relocation raises detector mounting risk
- Potential detector fall could cause life-threatening injuries
- No injuries or incidents reported at this time
- Recall active as of 2025-10-29
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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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