GE HealthCare recalled 1,386 Millennium MG/MC dual-head gamma cameras used in cardiac imaging worldwide. The recall notes devices past End of Guaranteed Service may have been transported without adequate detector support, risking mounting failure and possible detector falls. Facilities should stop using the devices and await recall instructions sent by GE Medical Systems Israel, Functional Imaging
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.
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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Nuclear medicine gamma cameras are used in hospitals and imaging centers for cardiac imaging and other diagnostic studies.
Moving or relocating units without proper detector mounting support can cause mounting stress and detector falls, risking life-threatening injuries.
This recall is not part of a broader industry pattern.
Hospitals may experience downtime and must coordinate with GE HealthCare for service options to protect patient safety.
Recall notice and FDA enforcement report Z-0297-2026; GE HealthCare customer support for instructions.
No refunds are described. Service, replacement, or loaner options will be arranged by GE HealthCare. Timelines vary by facility.
Keep the recall letter, device serial numbers, photos, and all correspondence with GE HealthCare.
Model: Millenium MG/MC dual-head gamma camera. Units recalled: 1,386. Distribution: Worldwide.
No injuries or incidents have been reported.
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