GE HealthCare issued a Class I recall on its Nuclear Medicine 600/800 series due to a product design flaw that could injure patients. The company recommended that customers not use the equipment until a GE HealthCare service technician performs an inspection.
Why did the company issue the recall and what are the potential impacts?
What does the product do?
Healthcare professionals use the GE Nuclear Medicine 600 and 800 series systems to create images of the body to aid in diagnosing trauma, diseases, disorders and abnormalities. These images help healthcare providers diagnose and detect issues with organ function and conditions such as cancer, cardiovascular disease and neurological disorders.
Why was the product recalled?
The manufacturer identified a defect in two mechanisms intended to prevent uncontrolled detector movement that could cause the machines to fall. The affected devices contain a ball screw that could fail and lack a safety key designed to prevent the machine from falling when such a failure occurs.
What are the risks to patients?
Though there have been no instances of injuries, deaths or complaints related to the defective devices, the potential seriousness of a failure prompted the company to issue the recall. The machines weigh more than 1,200 pounds and a fall could result in serious injuries or deaths if the device traps or crushes a patient.
Healthcare providers who use these machines should get the machines inspected and repaired before using them. Consumers who believe the machines caused them harm can report their experience through the FDA’s MedWatch system.
