The Food & Drug Administration has issued a recall on Philips’ Forte Gamma Camera System, citing concerns it may crush patients.
Issuing a Class I recall—the most serious of its kind—the FDA said the 660-pound detector could become detached “without warning” and crush or trap a patient, resulting in serious injury or death.
Philips Medical Systems (Cleveland) has recalled 852 of its devices distributed across the United States between January 1998 and December 2008.
The Forte Gamma Camera System is designed for SPECT scans, and is used to view images of structures or functions inside a patient’s body.
In September, Philips Medical Systems issued a letter to customers who purchased the system, urging them to stop using the camera and to complete a customer response form.
Philips has received one complaint thus far, with no serious injuries or deaths reported.
Completed response forms can be emailed to CTNM.QARA@Philips.com. Questions can be answered by a local Philips representative at 1-800-722-9377.