GE HealthCare recalled 82 Millenium Myosight dual-head gamma cameras distributed worldwide. The devices could have been moved without adequate detector mounting support. This could cause a detector fall and life-threatening injury. Hospitals and healthcare providers should stop using the cameras immediately and follow manufacturer recall instructions.
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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The Millenium Myosight gamma camera is a dual-head nuclear medicine imaging device used to perform cardiac imaging studies in hospitals. It requires precise detector mounting to ensure accurate imaging.
If the detector mounting is stressed due to improper handling, the detector could detach or fall, posing a serious risk to patients and staff.
This recall is not described as part of a broader industry-wide pattern.
Hospitals may experience equipment downtime and require service interventions. The recall pertains to life-threatening injury risk during transport or relocation of the device.
Serial numbers should be on the device label near the detector mounting and in the facility's service records.
Manufacturer guidance will specify remediation steps and timelines. Typical hospital remediation can span weeks to months depending on service parts.
Photograph device labels, keep the recall notice and correspondence, log serial numbers and relocation histories.
Product: Millenium Myosight dual-head gamma camera. Serial numbers: All serial numbers in distribution. Sold: Worldwide. Recall date: 2025-09-12. Price: Unknown.
No injuries or incidents have been reported.
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