FDA-Device2024-02-14Class I
BrightView XCT, gamma camera for SPECT; Model Nos.: 6-digit format 882482; 12-digit format 453560462131 453560749161
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
106 US; 241 OUS
Manufactured in
222 Jacobs St, Cambridge, MA, United States
Products
BrightView XCT, gamma camera for SPECT; Model Nos.: 6-digit format 882482; 12-digit format 453560462131 453560749161
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0931-2024Don't want to check this manually?
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