Quick Facts at a Glance
- Recall Date
- September 12, 2025
- Hazard Level
- HIGH
- Brand
- 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 Optima NX is a dual-head gamma camera used in nuclear medicine for cardiac imaging. Hospitals rely on its imaging capability for diagnostic procedures.
Why This Is Dangerous
If the unit is moved without proper detector support, mounting mechanisms can experience excessive stress, risking detachment and a potential detector fall.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Hospitals must halt use of the unit until guidance is provided. The impact includes disruption to imaging services and potential safety risks to patients and staff.
Practical Guidance
How to identify if yours is affected
- Confirm device is GE Optima NX dual-head gamma camera used for cardiac imaging.
- Review distribution status: all serial numbers in distribution are referenced in the recall.
- Check for recall notification from GE and the FDA page linked in the notice.
Where to find product info
Recall notices and device identifiers are documented on the FDA enforcement page and GE’s guidance communications.
What timeline to expect
Recall is active. Hospitals will receive specific remediation steps from GE; timelines will vary by facility.
If the manufacturer is unresponsive
- Escalate to hospital risk management or biosafety offices.
- File inquiries with GE Medical Systems Israel Functional Imaging.
- If needed, contact regulatory authorities for guidance.
How to prevent similar issues
- Ensure all detectors are properly supported during any relocation or service work.
- Adhere strictly to service manuals and manufacturer relocation procedures.
- Maintain updated service records and confirm detector mounting integrity after any movement.
Documentation advice
Keep copies of all recall notices, correspondence with GE, service records, and any related photos or reports.
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Product Details
Model numbers: All serial numbers in distribution Where sold: Worldwide When sold: Unknown Price: Unknown
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- End of Guaranteed Service context cited by manufacturer
- Immediate action required for healthcare facilities
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