Home / Recalls / Medical Devices
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING recalls Millenium MG/MC; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
Recalled October 29, 2025 · FDA recall Z-0297-2026 · GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL 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. · FDA Class II
Units
1386 units
Sold at
Worldwide
Description
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.
Product
Millenium MG/MC; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
Manufacturer(s)
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Made in
Israel
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →