Philips recalls gamma camera due to risk of head failure

By staff writers

November 5, 2019 -- Philips Healthcare is recalling its Forte gamma cameras due to the risk that one of the system's detector heads could become detached and injure patients, according to the U.S. Food and Drug Administration (FDA). No injuries have been reported.

Forte is an open-style dual-head SPECT gamma camera that was launched in 1998 by ADAC Laboratories, a dedicated nuclear medicine vendor that Philips acquired in December 2000. The system was manufactured up until 2008.

The recall was launched after a Forte user filed a complaint about the system, which sports two 660-lb detector heads. The recall covers multiple Forte models manufactured between 1998 and 2008. The recall covers 852 devices, according to the FDA.

Philips notified customers of the recall on September 19. The recall recommended that customers discontinue use of Forte systems until further notice and submit a report online about their systems using the FDA's MedWatch program.

In an official statement, Philips noted that it is asking customers to stop using all Forte gamma cameras in the field.

"Philips is notifying customers of a worldwide Field Safety Notice for the Philips Forte Gamma Camera system, a system that was produced by Philips up to 2008," the statement reads. "Philips has become aware of a single instance in which the detector unit on the Philips Forte Gamma Camera unexpectedly moved. Out of an abundance of caution, Philips is advising customers to immediately halt use of the Philips Forte Gamma Camera system, until the company can implement a device correction."

The statement reiterated that there were no reports of harm occurring to either patients, operators, or bystanders due to use of the system.

Copyright © 2019

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