GE HealthCare Recalls SMV DSXi Nuclear Medicine Gamma Camera (205 Units) for Cardiac Imaging
GE HealthCare recalled 205 SMV DSXi dual-head nuclear medicine gamma cameras used for cardiac imaging distributed worldwide. The recall cites potential detector mounting stress after End of Guaranteed Service. Hospitals should stop using these devices and follow the manufacturer’s recall instructions. Contact GE Medical Systems Israel Functional Imaging or a healthcare provider for guidance.
Quick Facts at a Glance
Recall Date
September 12, 2025
Hazard Level
HIGH
Brands
GE HealthCare, Sopha Medical Vision
Category
Health & Personal Care
Sold At
Unknown
At-Risk Groups
GENERAL
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
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About This Product
Dual-head nuclear medicine gamma cameras from SMV are used for cardiac imaging in medical facilities. They help image cardiac blood flow and function.
Why This Is Dangerous
If the detector mounting is compromised due to inadequate support during transport or relocation after service ends, the detector could detach or fall, risking serious injury.
Industry Context
This recall is not described as part of a broader industry pattern in the provided data.
Real-World Impact
Hospitals must avoid using affected cameras until cleared. The recall could affect patient safety and imaging workflow, with potential procurement delays.
Practical Guidance
How to identify if yours is affected
Identify DSXi, DST-XLi, DST-XL, and DSTi models in distribution.
Confirm distribution status as worldwide.
Check for manufacturer recall communications to determine eligibility for service or replacement.
Where to find product info
Refer to the FDA recall page linked in the notice and GE HealthCare communications for model numbers and serial ranges.
What timeline to expect
Recalls typically require vendor-provided service or replacement steps; exact timelines are not stated in the release.
If the manufacturer is unresponsive
Escalate to hospital’s risk management or procurement office.
Contact FDA if the manufacturer does not respond within a reasonable timeframe.
How to prevent similar issues
Ensure clear procedures for transporting sensitive imaging equipment.
Verify detector mounting integrity before relocation.
Monitor End of Guaranteed Service timelines with service providers.
Documentation advice
Maintain copies of recall notices, service correspondence, and any replacement agreements.
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