GE HealthCare recalled 292 Millenium MPR dual-head gamma cameras worldwide after discovering some units past End of Guaranteed Service may have been transported without adequate detector support. This can place excessive stress on detector mounting and could result in a detector fall with life-threatening injury. Healthcare facilities should stop using the devices immediately and follow recall PIN
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 MPR is a dual-head gamma camera used in nuclear medicine for cardiac imaging. Hospitals rely on these devices for myocardial perfusion imaging and similar procedures.
If moved without proper detector mounting support, detector mounting could fail. A detector fall could cause life-threatening injuries to patients or staff.
This recall is not described as part of a broader industry pattern in the notice.
Hospitals and clinics with affected units must halt use and follow the recall instructions. The recall could disrupt imaging services and require equipment inspection or replacement.
Refer to the manufacturer's recall letter and the FDA enforcement page for Z-0299-2026. Check device labels for model information.
Remedies and replacement instructions will be communicated by GE HealthCare via letter; no general timeline is provided.
Keep the recall letter, model and serial information, and all communications with GE HealthCare. Document any actions taken and dates.
Product: Millenium MPR dual-head gamma camera. Model numbers: All serial numbers in distribution. Sold worldwide through medical distributors. When sold: Unknown. Price: Unknown.
No injuries or incidents have been reported.
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