GE HealthCare issued a recall of 688 of its Nuclear Medicine 600/800 Series Systems after identifying an issue that could lead to the machine's detector falling and trapping or crushing a patient. In a Feb. 15 statement, the FDA classified this as a Class I recall because the faulty machines could result in serious injury or death.
The reason for the recall is that "there is a risk that the ball screw that serves as design mitigation for the suspended mass of the detector may fail," the FDA recall statement said. "Additionally, some devices are also missing a safety key that should prevent the detector from a catastrophic fall when the ball screw fails. If the ball screw fails and the safety key is missing, the 1212-pound (550-kg) detector could fall, potentially crushing or trapping a patient, which may result in serious injury or death."
There have not been any reports of injuries or deaths related to the issue.
The recalled products, distributed between April 1, 2018, and Dec. 16, 2022, include Nuclear Medicine 600/800 Series systems models Brivo 615; Discovery NM 630; Optima 640; Discovery NM/CT: 670 DR, 670 ES, 670 Pro, 670 CZT; NM: 830, 830ES; and NM/CT: 850, 850 ES, 860, 860 ES, 870 CZT, 870 DR and 870 ES.
GE first sent an Urgent Medical Device Correction letter to hospitals using these nuclear medicine machines on Dec. 18, identifying and notifying them of the potential risks. The letter recommended healthcare systems stop using the machines until an inspection was completed by GE's service technicians. Of the approximately 1,850 potentially affected systems, GE Healthcare has inspected nearly all that are installed, and eight were found with a missing safety key. These systems were corrected and returned back to clinical use, the company said.
"Patient safety is our top priority. 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 GE Healthcare spokesperson told Becker's. "There are no reports of patient injury or detector collapse as a result of this issue."
The company said it is working diligently to complete the remaining inspections as soon as possible.