The FDA yesterday announced a Class I recall of 22 different models of nuclear cameras sold by GE Healthcare, some of which have been on the market since 1992.
The systems affected include Infinia Nuclear Medicine Systems (11 models), VG and VG Hawkeye Nuclear Medicine Systems (6 models), Helix Nuclear Medicine Systems, Brivo NM615, Discovery NM630, Optima NM/CT640, and Discovery NM/CT670.
Indicating that serious injuries or deaths could occur, the FDA recommends that facilities cease using the systems and models referred to in the recall notice until a GE Healthcare field engineer completes inspection of the system and performs any needed repairs.
GE Healthcare first became aware of the problem on June 5, when a patient at a VA Medical Center hospital died as a result of injuries sustained when a part of the Infinia Hawkeye 4 nuclear medicine system collapsed during the scan.
According to the recall notice, GE sent an Urgent Medical Device Correction letter to all affected customers on June 17, recommending that qualified service personnel maintain the equipment and that maintenance be performed according to label recommendations.
A subsequent letter sent on July 3 identified the source of the problem (loose bolts that secured the camera to the gantry) and extended the recall beyond the previously identified Infinia, Hawkeye, and Helix models to include Brivo, Discovery, Optima models. The letter assured hospitals that they would be contacted by a GE Healthcare service representative as soon as possible.
The recall notice referred questions to an 800-number that would connect with a GE Healthcare Service Representative: 800-437-1171.