GE HealthCare has nearly completed its previously announced safety recall of the company's 600 and 800 series nuclear medicine systems.
"We have completed nearly all inspections of potentially impacted devices to ensure the safety key mitigation was appropriately implemented and cleared those systems for clinical use," a company spokesperson told AuntMinnie.com.
The U.S. Food and Drug Administration in FDA in February had classified the recall of certain GE HealthCare nuclear medicine systems as class I -- its most serious. The recall involved two mechanical issues: a possible failure of a ball screw that serves as design mitigation for the suspended mass of the detector, and that some machines may be missing a safety key that prevents the detector from falling in the event of a ball screw failure. The recall notice stated that if the ball screw fails and the safety key is missing, the 1,212-lb (550-kg) detector could fall, potentially crushing or trapping a patient.
The recalled systems include the following:
- Brivo 615
- Discovery NM 630
- Optima 640
- Discovery NM/CT: 670 DR, 670 ES, 670 Pro, 670 CZT
- NM: 830, 830ES
- NM/CT: 850, 850 ES, 860, 860 ES, 870 CZT, 870 DR, 870 ES
GE HealthCare said that it has inspected nearly all of the 1,850 potentially impacted systems and found eight systems that were missing a safety key. These systems were corrected and returned to clinical use, according to the vendor.
The company said there are no reports of patient injury or detector collapse due to this issue and that it is "making every effort" to complete the remaining inspections "as soon as possible."
