Philips Gets Another Recall Considered Class I by FDA

Philips North America’s recall of its Brightview gamma camera system, used in nuclear medicine, has been deemed Class I by the FDA for the potential of the camera falling on the patient.

According to the FDA, the detector on the Brightview, Brightview X and Brightview XCT models may unexpectedly fall due to a component failure. If the detector is positioned below center of gantry (a scanning unit), there is potential for abrasion, contusion, laceration or fracture of the patient’s legs. If the detector is positioned above or below center of gantry, there may be an interruption to normal system operation. There are 464 affected units in the U.S. and 551 units outside the U.S.

Philips’ Brightview gamma cameras also had Class 2 recalls in 2009, 2011, 2013-2019, and January 2024, according to the FDA recall database.

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