GE Medical Systems Israel recalls 11 Elscint Cardial dual-head gamma cameras used for cardiac imaging worldwide. The recall concerns detector mounting that could fail if the unit is moved without proper support. Hospitals should stop using these devices immediately and follow GE’s 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 Elscint Cardial dual-head gamma camera is a nuclear medicine device used for cardiac imaging. It captures functional information about heart tissue to help diagnose conditions.
If the detector mounting is stressed during transport or relocation and fails, a detector could detach and fall, creating a risk of life-threatening injury.
This recall is not described as part of a broader industry pattern in the notice.
The recall affects healthcare facilities globally. The immediate risk is to patients and staff should a detector fall occur during handling or relocation.
Recall letter from GE and FDA enforcement page linked in notice. Identifiers can also be on the device label or service records.
Manufacturer communications will provide timelines for remedies which may involve inspections, repairs, or replacements.
Document all communications with GE, any corrective actions, and any incident reports related to device handling.
Product: Elscint Cardial dual-head nuclear medicine gamma camera for cardiac imaging Brand: GE Medical Systems Israel / Functional Imaging Quantity recalled: 11 units Distribution: Worldwide Sold from: Unknown Price: Unknown Model numbers: All serial numbers in distribution
No injuries or incidents have been reported.
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