FDA-Device2024-02-21Class II
CombiDiagnost R90 1.0 (709030)
PHILIPS MEDICAL SYSTEMS
Hazard
While performing a fluoroscopy examination, there is a potential that the Radio Fluoroscopy (RF) viewer will also display a previous patient's radiography images. If the issue occurs, there will be differences in image content, image format and image size.
Sold states
US Nationwide distribution in the states of CA, FL, GA, IL, IN, KS, MD, ME, MI, MN, NC, NJ, NY, TX, VA, WA.
Affected count
86 units
Manufactured in
222 Jacobs St, N/A, Cambridge, MA, United States
Products
CombiDiagnost R90 1.0 (709030)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1087-2024Don't want to check this manually?
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