United StatesElscint Cardial and 13 other dual‑head nuclear medicine gamma camera models used for cardiac imaging (all serial numbers in distribution) are affected. GE HealthCare says systems past their End of Guaranteed Service may have been moved without adequate detector support, which can stress detector mounting mechanisms, potentially causing a detector to fall and result in life‑threatening injury.
What's being recalled
Elscint Cardial; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
Elscint Model 4XX; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
Elscint SPX4; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
Elscint SPX6; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
Elscint Varicam; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
Elscint Helix; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
Maxicam; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
Millenium MG/MC; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
Millenium Myosight; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
Millenium MPR; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
Millenium MPS; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
Optima NX; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
Sopha Medical Vision (SMV) DSXi/DST-XLi,/ DST-XL/ DSTi; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
Starcam/Camstar; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
Recalling firm: Ge Medical Systems Israel, Functional Imaging, Haifa, Israel.
How to identify it
all serial numbers in distribution
The 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.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Worldwide
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)
Canada