by John R. Fischer
, Senior Reporter | February 17, 2023
GE HealthCare is warning providers to refrain from using its Nuclear Medicine 600 and 800 Series scanners, having recalled the systems due to faulty mechanisms that could put patients and providers at risk of serious injury or death.
At issue is a deficient ball screw that cannot stop the uncontrolled movement in the 1,200-pound suspended detector. Should this happen, a safety key is supposed to stop the detector from falling, but some are missing this feature. Should both issues be present, the detector may fall and potentially crush or trap someone underneath.
The recall affects 688 devices distributed between April 2018 and December 2022, according to the FDA. They include 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.
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In a statement, a GE HealthCare spokesperson said that "patient safety is our top priority," and that the company has "completed nearly all inspections of potentially impacted devices."
Out of nearly 1,900 potentially impacted systems, only eight were missing a safety key, and all were repaired and cleared for clinical use once more. There have been no reports of patient injuries or detector collapses.
The 600 and 800 Series scanners are used to assess organ function or detect and diagnose issues such as cardiovascular disease, neurological disorders, cancer and trauma-related injuries.
GE HealthCare alerted customers in an Urgent Medical Device Correction Letter sent on December 18. “The company recommended customers stop use of these nuclear medicine systems until an inspection is completed by GE HealthCare service technicians,” said the FDA in its own alert.
The fall risk is due to issues with process control in the making of the machines, according to the agency.
“It is also important to note that the safety key is not visible to or accessible by the patient or the technician who operates it,” said the FDA. "Only a service technician can inspect it and provide a correction."