The Food and Drug Administration has issued a Class 1 recall—its most serious such notice—of the Forte Gamma Camera System, worried it could cause serious injury or even death.
Concerns stem from the possibility that the 660-pound system’s detector may become detached from the device without warning, potentially crushing or trapping patients, according to an FDA notice issued Monday, Nov. 4.
The Forte Gamma Camera System is used for viewing images of structures or functions inside the body for diagnosis, treatment and evaluation of numerous conditions. Phillips Medical Systems (Cleveland) has now recalled 852 of the devices across the U.S., manufactured between 1998 and 2008.
The company had received one complaint prior to the recall, and has not reported any serious injuries or deaths. Phillips also sent a letter to customers back in September, urging them to discontinue use of the system and complete a customer response form.
Those seeking additional information or support can call their local Phillips rep at 800-722-9377, the FDA said.