GE HealthCare recalled 1 Optima NX dual-head gamma camera worldwide after detecting potential detector mounting failure if the unit is moved without proper support. The risk could cause a detector fall and life-threatening injury. Hospitals should stop using the device and follow the manufacturer’s recall instructions. Contact GE Medical Systems Israel Functional Imaging for guidance.
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 Optima NX is a dual-head gamma camera used in nuclear medicine for cardiac imaging. Hospitals rely on its imaging capability for diagnostic procedures.
If the unit is moved without proper detector support, mounting mechanisms can experience excessive stress, risking detachment and a potential detector fall.
This recall is not described as part of a broader industry pattern.
Hospitals must halt use of the unit until guidance is provided. The impact includes disruption to imaging services and potential safety risks to patients and staff.
Recall notices and device identifiers are documented on the FDA enforcement page and GE’s guidance communications.
Recall is active. Hospitals will receive specific remediation steps from GE; timelines will vary by facility.
Keep copies of all recall notices, correspondence with GE, service records, and any related photos or reports.
Model numbers: All serial numbers in distribution Where sold: Worldwide When sold: Unknown Price: Unknown
No injuries or incidents have been reported.
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