medical Class I Updated 2024-02-14

Philips North America recalls BrightView, gamma camera system; Model Nos.: 6-digit f

Recalled Product

BrightView, gamma camera system; Model Nos.: 6-digit format 882480; 12-digit format 453560279781 453560279791 453560279811 453560279801; 4x4 digit format 2170-3000A 2170-3001A 2170-3002A 2170-3003A


Hazard / Issue

Detector may unexpectedly fall due to a component failure. If the detector is positioned below center of gantry, there is a potential for abrasion, contusion, laceration, and/or fracture to the patient's lower limbs, as well as an interruption to normal system operation. If detector is positioned above center of gantry, there may be an interruption to normal system operation.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: All serial numbers are affected. No UDI-DI available for this product.
View official government recall

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