FDA-Device2024-09-04Class II
DR 800. Digital Radiography X-ray System.
Agfa N.V.
Hazard
Potential for the front lever chain of the DR 800 table to fail.
Sold states
Worldwide - US Nationwide distribution in the states of CA, FL, IL, IN, KS, LA, MA, MO, NJ, NC, OH, OK, SC, VA, WV, WI; and the countries of AU, BE, BW, CA, CO, CZ, DE, ES, FR, GB, GR, IL, IN, IT, KZ, MX, PL, RS, UZ, ZA.
Affected count
141 units
Manufactured in
Septestraat 27, Mortsel, Belgium
Products
DR 800. Digital Radiography X-ray System.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2738-2024Don't want to check this manually?
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