Quick Facts at a Glance
- Recall Date
- September 12, 2025
- Hazard Level
- HIGH
- Brand
- GE Medical Systems Israel
- 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 Medical Systems Israel
- Product type
- Dual-head Nuclear Medicine Gamma Camera (Elscint Varicam)
- Model numbers
- All serial numbers in distribution
- 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 Varicam gamma camera is a dual-head imaging device used in nuclear medicine for cardiac imaging. It is typically deployed in clinical settings for diagnostic procedures.
Why This Is Dangerous
If moved without proper detector support, excessive stress can be placed on detector mounting mechanisms, risking detector detachment and bodily injury to patients and staff.
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 certain imaging procedures temporarily. The recall highlights the importance of proper equipment handling and service readiness for aging medical devices.
Practical Guidance
How to identify if yours is affected
- Identify if your facility uses an Elscint Varicam dual-head gamma camera.
- Check that the device is within distribution serial numbers scope (all serial numbers).
- Review service history and relocation records for the devices.
- Contact GE Medical Systems Israel, Functional Imaging for instructions.
Where to find product info
Recall notice and serial number guidance are available via FDA enforcement pages. Device serial numbers should be on the device nameplate and service records.
What timeline to expect
Remediation actions will be conducted as directed by the manufacturer. Replacement or service actions timelines will be communicated by GE Medical.
If the manufacturer is unresponsive
- Escalate to the hospital biosafety officer or risk/compliance department.
- File a report with the appropriate medical device regulatory body if necessary.
- Maintain records of all correspondence with the manufacturer.
How to prevent similar issues
- Maintain current service agreements and follow-up on End of Guaranteed Service status.
- Do not relocate imaging equipment without manufacturer authorization.
- Ensure detector mounting supports are intact and inspected during any transport.
- Document all movements and handling of heavy medical imaging equipment.
Documentation advice
Keep the recall notification, device serial numbers, relocation logs, and all communications with the manufacturer for record-keeping.
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Product Details
Model numbers: All serial numbers in distribution. Sold worldwide. Sold from: Unknown. Price: Unknown.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 15 units recalled worldwide
- Detector mounting risk could lead to detector fall
- Past End of Guaranteed Service period
- No injuries reported to date
- Immediate action required: stop using the device and await manufacturer instructions
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Safety Guide
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