FDA: Class I recall of Philips Medical System’s Forte Gamma Camera System

Editor's Note

The Food & Drug Administration (FDA) on November 4 identified Philips Medical System’s (Cleveland) recall of its Forte Gamma Camera System as Class I, the most serious.

The recall was initiated because of the potential for the detector, which weighs 660 pounds, to become detached from the device without warning and injure, crush, trap, or cause the death of a patient or a healthcare provider.

The company has received one complaint; no serious injuries or deaths were reported.

Manufacturing and distribution dates were January 1, 1998 to December 31, 2008.