Quick Facts at a Glance
- Recall Date
- September 12, 2025
- Hazard Level
- HIGH
- Brand
- GE HealthCare
- 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
- Product type
- Nuclear Medicine Gamma Camera
- 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 Starcam/Camstar dual-head gamma camera is used in nuclear medicine for cardiac imaging. Hospitals rely on these devices for diagnostic imaging procedures.
Why This Is Dangerous
The device could be moved without adequate detector support, causing stress on mounting hardware. This may lead to a detector fall and life-threatening injuries.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall affects hospital imaging workflows. Immediate device removal from service may cause temporary disruption in patient scheduling and imaging services.
Practical Guidance
How to identify if yours is affected
- Confirm the device is a GE HealthCare dual-head gamma camera used for cardiac imaging.
- Check if the serial number is among the recall notice: all serial numbers in distribution are included.
- Review the recall letter from GE HealthCare for specific instructions.
Where to find product info
Recall notice and instructions are available via the FDA enforcement page linked in the provided data.
What timeline to expect
Follow manufacturer instructions. Timelines for service or replacement will be provided by GE HealthCare.
If the manufacturer is unresponsive
- Document all contact attempts with the manufacturer.
- Escalate to hospital administration and regulatory authorities if the manufacturer is unresponsive.
How to prevent similar issues
- Do not relocate or transport gamma cameras without proper detector mounting and support.
- Verify and document detector mounting integrity during any service or relocation.
Documentation advice
Keep a copy of the recall letter, record serial numbers, capture photos of mounting hardware, and log all communications with the manufacturer.
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Product Details
Model numbers: All serial numbers in distribution. Where sold: Worldwide distribution to healthcare facilities. When sold: Unknown. Price: Unknown.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 102 units recalled worldwide
- All serial numbers in distribution are affected
- Hazard: detector mounting stress could lead to detector fall
- No injuries or incidents reported to date
- Stop use immediately and follow manufacturer recall instructions
- Contact GE HealthCare Israel, Functional Imaging or your provider for next steps
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Safety Guide
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