GE HealthCare Israel recalled 37 Maxicam dual-head gamma cameras distributed worldwide to hospitals. The recall cites potential detector mounting stress if the devices are moved without adequate support. This could result in a detector fall and life-threatening injury. Hospitals and healthcare providers should stop using the device and follow recall instructions from GE HealthCare.
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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Maxicam is a dual-head gamma camera used for cardiac imaging and other nuclear medicine applications.
If transported or relocated without adequate detector support, stress can damage detector mounting and lead to a detector fall.
This recall is not described as part of a broader industry pattern.
Hospitals may need to halt imaging procedures and coordinate with the manufacturer for replacement or service to prevent potential injuries.
Refer to the FDA enforcement report Z-0296-2026 and GE HealthCare recall communications.
Not specified by the recall notice.
Keep copy of recall notice, serial numbers, distribution list, and all correspondence with GE HealthCare and hospital staff.
Model numbers: Maxicam dual-head gamma camera. Sold to: Hospitals and clinics worldwide. When sold: Prior to recall date. Price: Unknown.
No injuries or incidents have been reported.
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