GE HealthCare recalled 102 dual-head gamma cameras used for cardiac imaging worldwide after finding that some systems past the End of Guaranteed Service could be moved without adequate detector support. This could place excessive stress on detector mounting mechanisms and may cause a detector to fall, posing life-threatening risk. Hospitals and healthcare providers should stop using the devices IM
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 Starcam/Camstar dual-head gamma camera is used in nuclear medicine for cardiac imaging. Hospitals rely on these devices for diagnostic imaging procedures.
The device could be moved without adequate detector support, causing stress on mounting hardware. This may lead to a detector fall and life-threatening injuries.
This recall is not part of a broader industry pattern.
The recall affects hospital imaging workflows. Immediate device removal from service may cause temporary disruption in patient scheduling and imaging services.
Recall notice and instructions are available via the FDA enforcement page linked in the provided data.
Follow manufacturer instructions. Timelines for service or replacement will be provided by GE HealthCare.
Keep a copy of the recall letter, record serial numbers, capture photos of mounting hardware, and log all communications with the manufacturer.
Model numbers: All serial numbers in distribution. Where sold: Worldwide distribution to healthcare facilities. When sold: Unknown. Price: Unknown.
No injuries or incidents have been reported.
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