Quick Facts at a Glance
- Recall Date
- September 12, 2025
- Hazard Level
- HIGH
- Brand
- GE HealthCare
- 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 HealthCare
- Product type
- Nuclear medicine gamma camera
- Model numbers
- Maxicam dual-head gamma camera, 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
Maxicam is a dual-head gamma camera used for cardiac imaging and other nuclear medicine applications.
Why This Is Dangerous
If transported or relocated without adequate detector support, stress can damage detector mounting and lead to a detector fall.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Hospitals may need to halt imaging procedures and coordinate with the manufacturer for replacement or service to prevent potential injuries.
Practical Guidance
How to identify if yours is affected
- Verify device is a Maxicam dual-head gamma camera.
- Check if serial number is within distribution scope (all serial numbers in distribution).
- Compare device status with recall notice and FDA listing.
Where to find product info
Refer to the FDA enforcement report Z-0296-2026 and GE HealthCare recall communications.
What timeline to expect
Not specified by the recall notice.
If the manufacturer is unresponsive
- Document outreach attempts and follow up with hospital biosafety or biomedical engineering.
- Escalate to FDA recall coordinator if vendor is unresponsive.
How to prevent similar issues
- Maintain detector mounting integrity during any movement.
- Implement recall guidance for handling, transport, and relocation of imaging systems.
- Ensure service providers are aware of recall and proper installation procedures.
Documentation advice
Keep copy of recall notice, serial numbers, distribution list, and all correspondence with GE HealthCare and hospital staff.
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Product Details
Model numbers: Maxicam dual-head gamma camera. Sold to: Hospitals and clinics worldwide. When sold: Prior to recall date. Price: Unknown.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- End of Guaranteed Service cited as trigger
- Detector mounting risk
- Life-threatening injury potential
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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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