GE HealthCare recalled 54 Millennium MPS dual-head gamma cameras sold worldwide to healthcare facilities. A detector mounting could fail if the unit is moved after its service life ends. Hospitals should stop using the device 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 Millennium MPS is a dual-head gamma camera used in cardiac nuclear imaging to assess myocardial perfusion.
If the device is moved without proper detector support, mounting may fail and detectors could fall, risking patient injury.
This recall is not part of a broader industry pattern.
Hospitals may need to suspend certain cardiac imaging procedures and arrange for service or replacement.
FDA enforcement page for recall Z-0300-2026; GE Medical Systems Israel recall notices.
4-8 weeks for remedy processing and replacement arrangements.
Keep recall letters, serial numbers, photos, and all communications for records.
Model: Millennium MPS dual-head gamma camera; Sold worldwide to healthcare facilities; Sold date: Unknown; Price: Unknown.
No injuries or incidents have been reported.
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