GE Healthcare has issued a recall for its Nuclear Medicine 600 and 800 Series systems, which healthcare professionals use to diagnose diseases, trauma, and disorders by creating images of the body. The recall has been issued due to a risk that the ball screw, which mitigates the suspended mass of the detector, may fail, and some devices may be missing a safety key that prevents the detector from falling catastrophically. Should the ball screw fail and the safety key is lost, the 1000-pound detector could fall down, causing serious injury or death to the patient. GE Healthcare identified and corrected eight different instances of the missing safety key during the recall.
Recalled Product Name: Nuclear Medicine 600/800 Series Systems
- Brivo 615
- Discovery NM 630
- 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.
- Optima 640
The affected nuclear medicine machines were distributed from April 1, 2018, until December 16, 2022.
Who is Affected By the GE Nuclear Medicine System Recall?
Patients who need nuclear medicine imaging requiring the use of a 600 or 800 Series system, healthcare settings that use these systems for imaging, and healthcare personnel who perform nuclear medicine imaging operating a 600 or 800 Series system may be affected by this recall. GE Healthcare is recommending that customers stop using the Nuclear Medicine systems until GE Healthcare service technicians complete an inspection. The company has also requested that customers complete an Acknowledgement Response form.
A GE Healthcare representative will contact customers to arrange for an inspection and any necessary corrections. During the inspection, a GE Healthcare engineer will ensure that all safety mitigations to prevent a fatal fall of the detector are in place and correct any issues with the safety mitigation devices. The engineer will also provide the customer with a release letter indicating that the unit can be returned to clinical use, provide updated service instructions, and apply a service label on an interior component to ensure future service activities follow the latest service instructions. Only a service technician can inspect the safety key and correct it as it is not visible or accessible to the patient or technician who operates it. No complaints, injuries, or deaths have been reported related to this issue, and GE Healthcare identified the issue internally.
CONTACT PARKER WAICHMAN LLP FOR A FREE CASE REVIEW
If you or a member of your family has been harmed by the GE Nuclear Medicine 600 and 800 Series system recall, Parker Waichman LLP is here to help. Our national personal injury law firm is ready to assist you in pursuing full compensation and legal justice. With a proven track record of success, we are committed to fighting for your rights and holding negligent parties accountable.
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