FDA-Device2024-01-17Class II
BrightView XCT, Gamma Camera, Product Code 882482
Philips North America
Hazard
While using Pre-Programmed Motion during an extrinsic quality assurance scan, a gap is created between the patient support and the detector, which may present a potential extremity entrapment hazard. Risk to patients may include fracture, body part loss of function/debilitation, muscle or ligament sprain or strain, laceration, crush injury, abrasion, or contusion.
Sold states
Domestic distribution nationwide. Foreign distribution worldwide.
Affected count
135 US; 294 OUS
Manufactured in
222 Jacobs St, Cambridge, MA, United States
Products
BrightView XCT, Gamma Camera, Product Code 882482
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0679-2024Don't want to check this manually?
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