GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING: Millenium MPR; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging

Hazard

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.

Details from the source

Reason for recall: 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. Distribution: Worldwide Quantity: 292 units Lot/code info: all serial numbers in distribution

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.