1200-pound Devices Could Fall on Patients
On February 15, the FDA issued a statement announcing a recall of certain nuclear medicine systems manufactured by GE Healthcare. The recall involves the 600/800 Series nuclear medicine systems, which are used to diagnose and treat a range of medical conditions. Affected models distributed between April 1, 2018 and December 16, 2022 are:
- 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
Risk of device failures
According to FDA, there is a risk that the detectors in these systems may detach and fall, potentially injuring patients or healthcare providers. The agency has classified this as a Class I recall, which is the most serious type of recall and indicates that there is a significant risk of harm.
The machines have two risk mitigations to prevent the 1,212-pound device from falling on a patient. The first is a ball screw to suspend the device, and a safety key that will suspend the device if the ball screw fails. If a device is missing a safety key and the ball screw fails, the machine could fall on a patient, causing serious injury or death.
Recall scope
The recall affects more than 3,600 units worldwide, including in the United States. GE Healthcare has instructed healthcare providers to immediately stop using the affected systems and to contact the company to schedule a service visit to have the detectors inspected and repaired as necessary.
FDA cause of action
While no injuries or deaths have been reported as a result of this issue, the FDA is taking this action to prevent potential harm to patients and healthcare providers. The agency recommends that healthcare providers using these systems should be vigilant and take appropriate measures to ensure patient safety.
Stress on equipment maintenance
This recall highlights the importance of regular equipment maintenance and testing in the healthcare industry. Healthcare providers should always prioritize patient safety and take swift action when issues are identified with medical equipment.
What patients should do
Patients who have received medical imaging or other procedures using the affected GE Healthcare nuclear medicine systems should contact their healthcare provider if they have any concerns. The FDA encourages patients and healthcare providers to report any adverse events related to the use of medical devices to the agency’s MedWatch program.
More information
Click here for more information about the recall.