FDA (Devices) recall action 97647
The FDA (Devices) publishes a recall like this one as 14 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 14 pages.
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.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
GE HealthCare is recalling 37 Maxicam gamma cameras because systems past guaranteed service may have been moved without adequate detector support, risking a detector fall.
GE HealthCare is recalling one Optima NX gamma camera because systems past guaranteed service may have been moved without adequate detector support, risking a detector fall.
GE HealthCare is recalling 102 Starcam and Camstar gamma cameras because systems past guaranteed service may have been moved without adequate detector support, risking a detector fall.
GE HealthCare is recalling 1,386 Millenium MG/MC gamma cameras because systems past guaranteed service may have been moved without adequate detector support, risking a detector fall.
GE HealthCare is recalling 11 Elscint Cardial gamma cameras because systems past guaranteed service may have been moved without adequate detector support, risking a detector fall.
GE HealthCare is recalling 45 Elscint SPX4 gamma cameras because systems past guaranteed service may have been moved without adequate detector support, risking a detector fall.
GE HealthCare is recalling 64 Elscint Model 4XX gamma cameras because systems past guaranteed service may have been moved without adequate detector support, risking a detector fall.
GE HealthCare is recalling 292 Millenium MPR gamma cameras because systems past guaranteed service may have been moved without adequate detector support, risking a detector fall.
GE HealthCare is recalling 15 Elscint Varicam gamma cameras because systems past guaranteed service may have been moved without adequate detector support, risking a detector fall.
GE HealthCare is recalling 82 Millenium Myosight gamma cameras because systems past guaranteed service may have been moved without adequate detector support, risking a detector fall.
GE HealthCare is recalling 205 Sopha Medical Vision gamma cameras because systems past guaranteed service may have been moved without adequate detector support, risking a detector fall.
GE HealthCare is recalling 54 Millenium MPS gamma cameras because systems past guaranteed service may have been moved without adequate detector support, risking a detector fall.
GE HealthCare is recalling three Elscint Helix gamma cameras because systems past guaranteed service may have been moved without adequate detector support, risking a detector fall.
GE HealthCare is recalling 28 Elscint SPX6 gamma cameras because systems past guaranteed service may have been moved without adequate detector support, risking a detector fall.