FDA (Devices) recall action 96079
The FDA (Devices) publishes a recall like this one as 13 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 13 pages.
GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products Details and Appendices) could have been transported or relocated without proper detector support, which can result in excessive load being applied to the detector mounting mechanisms. 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's Infinia nuclear medicine systems may have been transported without proper detector support, risking detector falls and life-threatening injury. The recall affects 93 units worldwide.
Certain GE Healthcare nuclear medicine systems were potentially transported without proper detector support, risking detector fall and life-threatening injury. Affected facilities should have their equipment inspected before clinical use.
GE Healthcare recalls certain nuclear medicine systems that could have been transported without proper detector support, risking detector falls and life-threatening injury.
GE Healthcare nuclear medicine systems including Infinia II Hawkeye 4 may have been transported without proper detector support, risking detector failure and serious injury.
GE Healthcare nuclear medicine imaging systems may have improper detector support following transport or relocation, potentially causing detector fall and life-threatening injury. The recall affects 36 systems distributed worldwide.
GE Healthcare is recalling 30 units of certain nuclear medicine imaging systems distributed worldwide. If transported without proper detector support, the systems risk detector mounting failure and life-threatening injury.
GE Healthcare recalls certain Infinia II and related nuclear medicine systems that may have been transported without proper detector support. This risk of detector fall could cause life-threatening bodily injury.
GE Healthcare is recalling Discovery NM/CT nuclear medicine imaging systems that may fail if transported improperly. Unsupported detectors risk mounting mechanism failure and detector fall, potentially causing life-threatening injury.
GE Healthcare is recalling certain nuclear medicine imaging systems that may have improper detector support from transport, creating a risk of detector fall and life-threatening bodily injury.
GE Healthcare has recalled certain nuclear medicine systems that could have detectors fall during improper transport, risking life-threatening injury. The recall affects 283 units worldwide.
GE Healthcare recalled 116 nuclear medicine imaging systems worldwide due to risk that systems transported without proper detector support could experience detector falls and life-threatening injury.
GE Healthcare's Discovery NM/CT 670 nuclear medicine imaging systems may have detectors that fall if not properly supported during transport or relocation, posing risk of life-threatening injury.
GE Healthcare is recalling 859 units of nuclear medicine imaging systems that may have been transported improperly, risking detector failure and potential life-threatening injury from detector falls.