GE Medical Systems Israel recalls 15 Elscint Varicam dual-head gamma cameras worldwide. The recall cites a risk that devices moved without proper detector support, which could cause a detector fall. Clinicians should stop using the devices and follow manufacturer instructions immediately.
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 Elscint Varicam gamma camera is a dual-head imaging device used in nuclear medicine for cardiac imaging. It is typically deployed in clinical settings for diagnostic procedures.
If moved without proper detector support, excessive stress can be placed on detector mounting mechanisms, risking detector detachment and bodily injury to patients and staff.
This recall is not described as part of a broader industry pattern in the provided information.
Hospitals may need to halt certain imaging procedures temporarily. The recall highlights the importance of proper equipment handling and service readiness for aging medical devices.
Recall notice and serial number guidance are available via FDA enforcement pages. Device serial numbers should be on the device nameplate and service records.
Remediation actions will be conducted as directed by the manufacturer. Replacement or service actions timelines will be communicated by GE Medical.
Keep the recall notification, device serial numbers, relocation logs, and all communications with the manufacturer for record-keeping.
Model numbers: All serial numbers in distribution. Sold worldwide. Sold from: Unknown. Price: Unknown.
No injuries or incidents have been reported.
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