FDA-Device2016-06-15Class II
Philips Healthcare DuraDiagnost stationary X-ray system
Philips Healthcare
Hazard
The detector may signal that it is ready for acquisition when it actually is not, resulting in failure to properly acquire the X-ray image.
Sold states
USA (nationwide) Distribution to the states of : ( DuraDiagnost) to the states of : OH, CA, WA and NE. (DigitalDiagnost) to the states of : AK, AZ, AL, CA, CT, CO, DE, FL, GA, HI, ID, KY, LA, MA, MN, MD, MS, ME, MO, NE, NY, ND, OH and PA.
Affected count
5
Manufactured in
3000 Minuteman Rd, N/A, Andover, MA, United States
Products
Philips Healthcare DuraDiagnost stationary X-ray system
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1696-2016Don't want to check this manually?
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