FDA-Device2024-02-14Class I
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
Philips North America
Hazard
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.
Sold states
Domestic distribution nationwide. International distribution worldwide.
Affected count
302 US; 264 OUS
Manufactured in
222 Jacobs St, Cambridge, MA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0929-2024Don't want to check this manually?
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